Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-02-25 @ 6:44 PM
Study NCT ID:
NCT03617458
Status:
COMPLETED
Last Update Posted:
2025-09-22
First Post:
2018-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D065627', 'term': 'Familial Primary Pulmonary Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ph_research@vumc.org', 'phone': '615-322-4703', 'title': 'Research Programs Manager', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected over study duration-baseline to 12-weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Metformin + mHealth Intervention', 'description': "Patients will receive active ingredient medicine with mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.\n\nSubjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po twice a day (BID) x 5 days, 500mg by mouth (po) three times a day (TID) x 5 days,1000mg po BID x 69 days (12 weeks total).\n\nMetformin: Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2.\n\nmHealth Intervention: Our Health Insurance Portability and Accountability Act (HIPAA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.Subjects assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.", 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 9, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'Placebo + Usual Care', 'description': "Patient will receive non active medicine and routine medical care.\n\nPlacebo: A treatment with no active ingredients or therapeutic effect.\n\nUsual Care: Our HIPAA data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.", 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 7, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Metformin + Usual Care', 'description': "Patient will receive active ingredient medicine with routine medical care.\n\nSubjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po BID x 5 days, 500mg po TID x 5 days,1000mg po BID x 69 days (12 weeks total).\n\nMetformin: Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2.\n\nUsual Care: Our HIPAA data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.", 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 14, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Placebo + mHealth Intervention', 'description': "Patient will receive non active medicine and the mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.\n\nPlacebo: A treatment with no active ingredients or therapeutic effect.\n\nmHealth Intervention: Our Health Insurance Portability and Accountability Act (HIPAA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.Subjects assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.", 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 9, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Gastrointestinal Issues', 'notes': 'Including issues like bloating, nausea, diarrhea, or discomfort. Deemed not to be serious events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intravenous Medication Line Malfunction/Infection', 'notes': 'Deemed not serious or relatable.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Common Pulmonary Hypertension Symptoms', 'notes': 'Complications are expected in patient population considering pulmonary hypertension diagnosis. Unrelated to study and expected.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 9, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'General Infection', 'notes': 'This included not relatable or serious adverse conditions such as cellulitis or general sore throat.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Intravenous Medication Line Malfunction/Infection', 'notes': 'Any issue with the Hickman Catheter that caused hospitalization was considered serious but non-related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Product Issues', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Biliary Colic', 'notes': 'Deemed not study related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Supraventriculartachycardia', 'notes': 'Resulted in hospitalizations but deemed not relatable.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism', 'notes': 'Deemed Non-study Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infections requiring Hospitalization', 'notes': 'Included two events,one with pneumonia and one with an upper respiratory infection. Both deemed not-relatable.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Bleed', 'notes': 'Bleed was deemed non-study related.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Clinical Worsening', 'notes': 'Related to routine Catheter procedure. Deemed non-study relatable.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Six Minute Walk Distance (Meters)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin + mHealth Intervention', 'description': "Patients will receive active ingredient medicine with mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.\n\nSubjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po twice a day (BID) x 5 days, 500mg by mouth (po) three times a day (TID) x 5 days,1000mg po BID x 69 days (12 weeks total).\n\nMetformin: Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2.\n\nmHealth Intervention: Our Health Insurance Portability and Accountability Act (HIPAA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.Subjects assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue."}, {'id': 'OG001', 'title': 'Placebo + Usual Care', 'description': "Patient will receive non active medicine and routine medical care.\n\nPlacebo: A treatment with no active ingredients or therapeutic effect.\n\nUsual Care: Our HIPAA data will be transmitted from the subject's smartphone to our mHealth platform via cellular network."}, {'id': 'OG002', 'title': 'Metformin + Usual Care', 'description': "Patient will receive active ingredient medicine with routine medical care.\n\nSubjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po BID x 5 days, 500mg po TID x 5 days,1000mg po BID x 69 days (12 weeks total).\n\nMetformin: Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2.\n\nUsual Care: Our HIPAA data will be transmitted from the subject's smartphone to our mHealth platform via cellular network."}, {'id': 'OG003', 'title': 'Placebo + mHealth Intervention', 'description': "Patient will receive non active medicine and the mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.\n\nPlacebo: A treatment with no active ingredients or therapeutic effect.\n\nmHealth Intervention: Our Health Insurance Portability and Accountability Act (HIPAA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.Subjects assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '414.5', 'spread': '87.9', 'groupId': 'OG000'}, {'value': '461.7', 'spread': '135.6', 'groupId': 'OG001'}, {'value': '448.9', 'spread': '85.9', 'groupId': 'OG002'}, {'value': '483.0', 'spread': '85.6', 'groupId': 'OG003'}]}]}, {'title': '12-Week', 'categories': [{'measurements': [{'value': '457.2', 'spread': '110.2', 'groupId': 'OG000'}, {'value': '474.9', 'spread': '123.6', 'groupId': 'OG001'}, {'value': '454.8', 'spread': '112.3', 'groupId': 'OG002'}, {'value': '485.6', 'spread': '72.3', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 12 weeks', 'description': 'The change in meters walked for the six-minute walk distance from baseline to week 12', 'unitOfMeasure': 'meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline to Week 12 in World Health Organization Functional Class (WHO FC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Metformin + mHealth Intervention', 'description': "Patients will receive active ingredient medicine with mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.\n\nSubjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po twice a day (BID) x 5 days, 500mg by mouth (po) three times a day (TID) x 5 days,1000mg po BID x 69 days (12 weeks total).\n\nMetformin: Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2.\n\nmHealth Intervention: Our Health Insurance Portability and Accountability Act (HIPAA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.Subjects assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue."}, {'id': 'OG001', 'title': 'Placebo + Usual Care', 'description': "Patient will receive non active medicine and routine medical care.\n\nPlacebo: A treatment with no active ingredients or therapeutic effect.\n\nUsual Care: Our HIPAA data will be transmitted from the subject's smartphone to our mHealth platform via cellular network."}, {'id': 'OG002', 'title': 'Metformin + Usual Care', 'description': "Patient will receive active ingredient medicine with routine medical care.\n\nSubjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po BID x 5 days, 500mg po TID x 5 days,1000mg po BID x 69 days (12 weeks total).\n\nMetformin: Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2.\n\nUsual Care: Our HIPAA data will be transmitted from the subject's smartphone to our mHealth platform via cellular network."}, {'id': 'OG003', 'title': 'Placebo + mHealth Intervention', 'description': "Patient will receive non active medicine and the mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.\n\nPlacebo: A treatment with no active ingredients or therapeutic effect.\n\nmHealth Intervention: Our Health Insurance Portability and Accountability Act (HIPAA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.Subjects assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue."}], 'classes': [{'categories': [{'title': 'Did not improve Functional Class', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}, {'title': 'Improved Functional Class by at least 1', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline and 12 weeks', 'description': "Change from baseline in WHO functional class at week 12. The World Health Organization (WHO) functional class system was created to define the severity of an individual's symptoms and how they impact on day-to-day activities. The columns represent the randomization assignment and the rows represent if a change in WHO functional class occurred by the participant from baseline to week 12.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Body Weight (Kilograms)', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change in body weight as measured by assessing weight in kilograms at baseline and at week 12.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Body Mass Index (BMI)', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline BMI at week 12. BMI is defined as a measure of body fat based on height and weight that applies to adult men and women.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Absolute Six-Minute Walk Distance (Meters)', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline six-minute walk test distance (meters) at week 12.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Borg Dyspnea Score', 'timeFrame': 'baseline and end of 12 weeks', 'description': "Change from baseline Borg dyspnea score at week 12.\n\nThe Borg dyspnea score is a measure of the physical activity intensity level based on the subject's perceived exertion. Subjects will rate at resting and peak exercise. Targets exercise capacity.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Emphasis-10 Quality of Life Survey Score', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline Emphasis-10 quality of life survey score at week 12. Survey completed at baseline and 12 weeks.\n\nThe emPHasis-10 is a short and easy questionnaire that consists of 10 items which address breathlessness, fatigue, control and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Daily Step Count, as Measured by the Mean Daily Step Count', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from the baseline mean daily step count at week 12. Data obtained by the mHealth device.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Daily Step Count Goal Attainment, as Measured by the Percentage (%) of Subjects Who Meet Their Daily Step Count Goal', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Assess the frequency (% of days) that the daily step target was achieved over time. Data obtained by the mHealth device.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Daily Aerobic Time (Minutes)', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline daily aerobic time at week 12. Aerobic time is defined as total time in minutes spent walking continuously for \\> 10 minutes without breaking for \\> 1 minute.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Total Daily Activity Assessed in Step Counts Per Minute', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'This variable will be assessed by FitBit and is expressed in step counts per minute. Mean value from the last week in the study will be evaluated and mean change from baseline will be calculated.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Resting Heart Rate (Beats Per Minute)', 'timeFrame': 'baseline and end of 12 weeks', 'description': "Monitored regularly using activity tracking device (per second when active, per 5 seconds when inactive). Subject's resting and peak exercise heart rate will also be recorded at baseline and week 12. Targets exercise capacity. Heart rate is expressed as beats per minute.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Homeostatic Model Assessment (HOMA)-Insulin Resistance (IR)', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline insulin resistance at week 12. Insulin resistance will be quantified using the homeostatic model assessment of insulin resistance (HOMA-IR), which estimates insulin resistance through fasting plasma insulin and glucose ratios. Targets mechanism of improved exercise capacity.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Laboratory Values of Plasma Estradiol Metabolites', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'As measured by plasma estradiol in pg/ml, DHEA in mcg/ml, total testosterone in ng/dl, bioavailable testosterone in ng/dl, progesterone in ng/ml, and sex hormone binding globulin (SHBG) in nmol/L at baseline and week 12. These laboratory values will be aggregated to assess the number of participants with abnormal laboratory values.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Laboratory Values of Urine Estradiol Metabolites', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'As measured by the laboratory values Estrone (E1), Estradiol (E2), 2-OHE1, 2-OHE2, 2-MeOE1, 2-MeOE2, 4-OHE1, 4-MeOE1, 4-MeOE2, 16a-OHE1, 17-epiE3, Estriol (E3), 16-ketoE2, 16-epiE3 with pM per mg of urine creatinine. These laboratory values will be assessed at baseline and week 12 and then aggregated to assess the number of participants with abnormal laboratory values.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Laboratory Values of Plasma Lipid Profile', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'As measured by total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and non - high-density lipoprotein cholesterol with mg/dl as the units of measure at baseline and week 12. These laboratory values will be aggregated to assess number of participants with abnormal laboratory values.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Laboratory Values of Plasma Free Fatty Acid Profiles', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'As measured by plasma free fatty acid profiles at baseline and week 12. Free fatty acids will be measured in mmol/L. This laboratory value will be assessed by the number of patients with abnormal laboratory values.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Laboratory Values of Plasma Acylcarnitine Profiles', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'As measured by plasma acylcarnitine profiles at baseline and week 12. We will be measuring the laboratory values of C2, C3, C3-dicarboxylic, C4, C4- hydroxyl, C4-dicarboxylic, C5, C5:1, C5 - hydroxy, C5-dicarboxylic, C6, C8, C10, C10:1, C10:2, C12, C14, C14:1, C14:2, C14-hydroxy, C16, C16:1, C161:-hydroxy, C16-hydroxy, C18, C18:1, C18:2, C18-hydroxy, C18:1-hydroxy, C18:2-hydroxy in the unit of measure nmol/L. These laboratory values will be aggregated to assess the number of participants with abnormal laboratory values.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Plasma Brain Natriuretic Peptide (BNP) Laboratory Value Measured in pg/ml', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline B-type natriuretic peptide (BNP) level at week 12. BNP is a marker of myocardial stress which decreases with exercise training and measured in pg/ml. Targets mechanism of improved exercise capacity.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Quadriceps Skeletal Muscle Triglyceride Content, as Measured by % Triglycerides', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline quadriceps Skeletal Muscle Triglyceride Content at week 12 as measured by % triglycerides.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Quadriceps Skeletal Muscle Fatigue, as Measured by Total Time to Muscle Fatigue During the Muscle Strength and Function Test', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline quadriceps Skeletal Muscle Fatigue at week 12 as measured by total time to muscle fatigue during the muscle strength and function test.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Quadriceps Skeletal Muscle Strength During the Muscle Strength and Function Test, as Measured by Maximum Contraction Strength', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline quadriceps Skeletal Muscle Strength during the Muscle Strength and Function Test at week 12 as measured by maximum contraction strength.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Quadriceps Skeletal Muscle Contractile Tissue Cross-sectional', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in quadriceps skeletal muscle contractile tissue cross-sectional at week 12 as measured by the relative change in the maximum cross-sectional area of muscle tissue of the quadriceps muscle group, measured in the axial anatomical plane.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in RV Myocardial Muscle Triglyceride Content, as Measured by % Triglycerides', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in right ventricle Myocardial Muscle Triglyceride Content results at week 12 as measured by % triglycerides.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Tricuspid Annular Plane Systolic Excursion (TAPSE), Expressed in mm.', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in Tricuspid Annular Plane systolic Excursion (TAPSE) expressed in mm on echocardiogram results at week 12.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Right Ventricle (RV) and Left Ventricle (LV) Ejection Fraction Values as Assessed by Echocardiogram Results, Expressed in Percentage (%).', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in RV and Left Ventricle (LV) Ejection Fraction values on echocardiogram results at week 12 and expressed in percentage (%).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Right Ventricle (RV) Fractional Area, as Assessed by Echocardiogram Results, Expressed in Percentage (%).', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in right ventricle Fractional Area on echocardiogram results at week 12 and expressed in percentage (%).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': "Change From Baseline in Tricuspid Annular Velocity (S'), as Assessed by Echocardiogram Results, Expressed in cm/Sec", 'timeFrame': 'baseline and end of 12 weeks', 'description': "Change from baseline in Tricuspid Annular Velocity (S') on echocardiogram results at week 12 and expressed in cm/sec.", 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Tricuspid Regurgitant (TR) Velocity, as Assessed by Echocardiogram Results, Expressed in m/Sec.', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in Tricuspid Regurgitant (TR) Velocity on echocardiogram results at week 12 and expressed in m/sec.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Estimated Right Ventricle (RV) and Right Atrial (RA) Pressure, as Assessed by Echocardiogram Results, Expressed in mmHg', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in the estimated right ventricle and right atrial pressure on echocardiogram results at week 12 and expressed in mmHg.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Right Ventricle (RV) and Left Ventricle (LV) Diastolic Function as Assessed by Doppler Inflow Patterns on Echocardiogram.', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in right and left ventricular diastolic function as assessed by Doppler inflow patterns on echocardiogram results at week 12', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Right Ventricle (RV) Free Wall Longitudinal Strain, as Assessed by Echocardiogram Results, and Expressed as Percent (%) Change in Myocardial Deformation.', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in right ventricle free wall longitudinal strain on echocardiogram results at week 12 and expressed as percent (%) change in myocardial deformation.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Participants With a Change in Screening Clinical Characteristics', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'To compare and define the screening clinical characteristics of responders and non-responders to mHealth intervention or no intervention and/or metformin at week 12. We will be taking into account all patient screening data including demographic information, medical history, current medication regimen, physical exam, 6MWT, echocardiogram, MRS, skeletal muscle function test, emphasis-10 survey, WHO functional class, and laboratory values. These results will be aggregated and the results compared to the same characteristics at the end of week 12.\n\nWe will be assessing the number of participants with a change in screening clinical characteristics.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Treatment - Emergent Adverse Events (Safety and Tolerability of mHealth Intervention and Drug Treatment in PAH Subjects)', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Number of treatment-related adverse events as assessed by telephone calls at baseline, week one, week three, week nine, week twelve, and week seventeen.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Patient Satisfaction of Treatment Interventions, as Measured by Change in Emphasis-10 Survey Score', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'We will be assessing patient satisfaction of treatment interventions by looking at the number of participants with an increase or decrease in overall score on the emphasis-10 questionnaire from screening and at the end of 12 weeks.\n\nThe emPHasis-10 is a short and easy questionnaire that consists of 10 items which address breathlessness, fatigue, control and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. EmPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Dropout Rate Incidence', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'To assess the effect of a mHealth intervention or no intervention and/or metformin or placebo on dropout rates over 12 weeks.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Number of Patients With a PAH-related Hospitalization Incidence', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'To assess the effect of a mHealth intervention or no intervention and/or metformin or placebo on PAH-related hospitalization incidences over 12 weeks. Number of patients will be assessed.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 12 in Patient Medication Regimen, as Measured by Percentage (%) of Subjects With a Change in Medication Regimen', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in patient medication regimen at week 12 as measured by percentage (%) of subjects with a change in medication regimen.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Incidence of Death', 'timeFrame': 'baseline to/and 12 weeks', 'description': 'To assess the effect of a mHealth intervention or no intervention and/or metformin or placebo on incidence of death over 12 weeks.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Metformin + mHealth Intervention', 'description': "Patients will receive active ingredient medicine with mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.\n\nSubjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po twice a day (BID) x 5 days, 500mg by mouth (po) three times a day (TID) x 5 days,1000mg po BID x 69 days (12 weeks total).\n\nMetformin: Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2.\n\nmHealth Intervention: Our Health Insurance Portability and Accountability Act (HIPAA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.Subjects assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue."}, {'id': 'FG001', 'title': 'Placebo + Usual Care', 'description': "Patient will receive non active medicine and routine medical care.\n\nPlacebo: A treatment with no active ingredients or therapeutic effect.\n\nUsual Care: Our HIPAA data will be transmitted from the subject's smartphone to our mHealth platform via cellular network."}, {'id': 'FG002', 'title': 'Metformin + Usual Care', 'description': "Patient will receive active ingredient medicine with routine medical care.\n\nSubjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po BID x 5 days, 500mg po TID x 5 days,1000mg po BID x 69 days (12 weeks total).\n\nMetformin: Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2.\n\nUsual Care: Our HIPAA data will be transmitted from the subject's smartphone to our mHealth platform via cellular network."}, {'id': 'FG003', 'title': 'Placebo + mHealth Intervention', 'description': "Patient will receive non active medicine and the mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.\n\nPlacebo: A treatment with no active ingredients or therapeutic effect.\n\nmHealth Intervention: Our Health Insurance Portability and Accountability Act (HIPAA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.Subjects assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '17'}, {'groupId': 'FG002', 'numSubjects': '19'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '18'}, {'groupId': 'FG003', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Recruitment occured between 8/23/2018-8/22/2023. Recruitment occurred in clinics at each of the participating sites.', 'preAssignmentDetails': 'There was a participant run-in for the fitbit portion of the study. Run-in was a 2-week period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Metformin + mHealth Intervention', 'description': "Patients will receive active ingredient medicine with mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.\n\nSubjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po twice a day (BID) x 5 days, 500mg by mouth (po) three times a day (TID) x 5 days,1000mg po BID x 69 days (12 weeks total).\n\nMetformin: Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2.\n\nmHealth Intervention: Our Health Insurance Portability and Accountability Act (HIPAA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.Subjects assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue."}, {'id': 'BG001', 'title': 'Placebo + Usual Care', 'description': "Patient will receive non active medicine and routine medical care.\n\nPlacebo: A treatment with no active ingredients or therapeutic effect.\n\nUsual Care: Our HIPAA data will be transmitted from the subject's smartphone to our mHealth platform via cellular network."}, {'id': 'BG002', 'title': 'Metformin + Usual Care', 'description': "Patient will receive active ingredient medicine with routine medical care.\n\nSubjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po BID x 5 days, 500mg po TID x 5 days,1000mg po BID x 69 days (12 weeks total).\n\nMetformin: Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2.\n\nUsual Care: Our HIPAA data will be transmitted from the subject's smartphone to our mHealth platform via cellular network."}, {'id': 'BG003', 'title': 'Placebo + mHealth Intervention', 'description': "Patient will receive non active medicine and the mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.\n\nPlacebo: A treatment with no active ingredients or therapeutic effect.\n\nmHealth Intervention: Our Health Insurance Portability and Accountability Act (HIPAA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.Subjects assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue."}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.4', 'spread': '17.4', 'groupId': 'BG000'}, {'value': '46.6', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '48.8', 'spread': '13.7', 'groupId': 'BG002'}, {'value': '47', 'spread': '12.2', 'groupId': 'BG003'}, {'value': '47.5', 'spread': '13.5', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '20', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '71', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '63', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '73', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-04-12', 'size': 1263067, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-09-09T18:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The investigators propose a phase II, 2x2 factorial randomized, blinded trial testing metformin versus placebo and a mobile health intervention (mHealth) versus usual care of 12 weeks.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'This is a phase II, 2x2 factorial randomized, blinded trial testing metformin versus placebo and a mHealth intervention (mHealth) versus usual care of 12 weeks.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'dispFirstSubmitDate': '2024-06-13', 'completionDateStruct': {'date': '2025-08-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2018-05-02', 'resultsFirstSubmitDate': '2024-09-12', 'studyFirstSubmitQcDate': '2018-07-31', 'dispFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2024-10-11', 'studyFirstPostDateStruct': {'date': '2018-08-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Six Minute Walk Distance (Meters)', 'timeFrame': 'baseline and 12 weeks', 'description': 'The change in meters walked for the six-minute walk distance from baseline to week 12'}, {'measure': 'Change From Baseline to Week 12 in World Health Organization Functional Class (WHO FC)', 'timeFrame': 'baseline and 12 weeks', 'description': "Change from baseline in WHO functional class at week 12. The World Health Organization (WHO) functional class system was created to define the severity of an individual's symptoms and how they impact on day-to-day activities. The columns represent the randomization assignment and the rows represent if a change in WHO functional class occurred by the participant from baseline to week 12."}], 'secondaryOutcomes': [{'measure': 'Change From Baseline to Week 12 in Body Weight (Kilograms)', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change in body weight as measured by assessing weight in kilograms at baseline and at week 12.'}, {'measure': 'Change From Baseline to Week 12 in Body Mass Index (BMI)', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline BMI at week 12. BMI is defined as a measure of body fat based on height and weight that applies to adult men and women.'}, {'measure': 'Change From Baseline to Week 12 in Absolute Six-Minute Walk Distance (Meters)', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline six-minute walk test distance (meters) at week 12.'}, {'measure': 'Change From Baseline to Week 12 in Borg Dyspnea Score', 'timeFrame': 'baseline and end of 12 weeks', 'description': "Change from baseline Borg dyspnea score at week 12.\n\nThe Borg dyspnea score is a measure of the physical activity intensity level based on the subject's perceived exertion. Subjects will rate at resting and peak exercise. Targets exercise capacity."}, {'measure': 'Change From Baseline to Week 12 in Emphasis-10 Quality of Life Survey Score', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline Emphasis-10 quality of life survey score at week 12. Survey completed at baseline and 12 weeks.\n\nThe emPHasis-10 is a short and easy questionnaire that consists of 10 items which address breathlessness, fatigue, control and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life.'}, {'measure': 'Change From Baseline to Week 12 in Daily Step Count, as Measured by the Mean Daily Step Count', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from the baseline mean daily step count at week 12. Data obtained by the mHealth device.'}, {'measure': 'Change From Baseline to Week 12 in Daily Step Count Goal Attainment, as Measured by the Percentage (%) of Subjects Who Meet Their Daily Step Count Goal', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Assess the frequency (% of days) that the daily step target was achieved over time. Data obtained by the mHealth device.'}, {'measure': 'Change From Baseline to Week 12 in Daily Aerobic Time (Minutes)', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline daily aerobic time at week 12. Aerobic time is defined as total time in minutes spent walking continuously for \\> 10 minutes without breaking for \\> 1 minute.'}, {'measure': 'Change From Baseline to Week 12 in Total Daily Activity Assessed in Step Counts Per Minute', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'This variable will be assessed by FitBit and is expressed in step counts per minute. Mean value from the last week in the study will be evaluated and mean change from baseline will be calculated.'}, {'measure': 'Change From Baseline to Week 12 in Resting Heart Rate (Beats Per Minute)', 'timeFrame': 'baseline and end of 12 weeks', 'description': "Monitored regularly using activity tracking device (per second when active, per 5 seconds when inactive). Subject's resting and peak exercise heart rate will also be recorded at baseline and week 12. Targets exercise capacity. Heart rate is expressed as beats per minute."}, {'measure': 'Change From Baseline to Week 12 in Homeostatic Model Assessment (HOMA)-Insulin Resistance (IR)', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline insulin resistance at week 12. Insulin resistance will be quantified using the homeostatic model assessment of insulin resistance (HOMA-IR), which estimates insulin resistance through fasting plasma insulin and glucose ratios. Targets mechanism of improved exercise capacity.'}, {'measure': 'Number of Participants With Abnormal Laboratory Values of Plasma Estradiol Metabolites', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'As measured by plasma estradiol in pg/ml, DHEA in mcg/ml, total testosterone in ng/dl, bioavailable testosterone in ng/dl, progesterone in ng/ml, and sex hormone binding globulin (SHBG) in nmol/L at baseline and week 12. These laboratory values will be aggregated to assess the number of participants with abnormal laboratory values.'}, {'measure': 'Number of Participants With Abnormal Laboratory Values of Urine Estradiol Metabolites', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'As measured by the laboratory values Estrone (E1), Estradiol (E2), 2-OHE1, 2-OHE2, 2-MeOE1, 2-MeOE2, 4-OHE1, 4-MeOE1, 4-MeOE2, 16a-OHE1, 17-epiE3, Estriol (E3), 16-ketoE2, 16-epiE3 with pM per mg of urine creatinine. These laboratory values will be assessed at baseline and week 12 and then aggregated to assess the number of participants with abnormal laboratory values.'}, {'measure': 'Number of Participants With Abnormal Laboratory Values of Plasma Lipid Profile', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'As measured by total cholesterol, triglycerides, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and non - high-density lipoprotein cholesterol with mg/dl as the units of measure at baseline and week 12. These laboratory values will be aggregated to assess number of participants with abnormal laboratory values.'}, {'measure': 'Number of Participants With Abnormal Laboratory Values of Plasma Free Fatty Acid Profiles', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'As measured by plasma free fatty acid profiles at baseline and week 12. Free fatty acids will be measured in mmol/L. This laboratory value will be assessed by the number of patients with abnormal laboratory values.'}, {'measure': 'Number of Participants With Abnormal Laboratory Values of Plasma Acylcarnitine Profiles', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'As measured by plasma acylcarnitine profiles at baseline and week 12. We will be measuring the laboratory values of C2, C3, C3-dicarboxylic, C4, C4- hydroxyl, C4-dicarboxylic, C5, C5:1, C5 - hydroxy, C5-dicarboxylic, C6, C8, C10, C10:1, C10:2, C12, C14, C14:1, C14:2, C14-hydroxy, C16, C16:1, C161:-hydroxy, C16-hydroxy, C18, C18:1, C18:2, C18-hydroxy, C18:1-hydroxy, C18:2-hydroxy in the unit of measure nmol/L. These laboratory values will be aggregated to assess the number of participants with abnormal laboratory values.'}, {'measure': 'Change From Baseline to Week 12 in Plasma Brain Natriuretic Peptide (BNP) Laboratory Value Measured in pg/ml', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline B-type natriuretic peptide (BNP) level at week 12. BNP is a marker of myocardial stress which decreases with exercise training and measured in pg/ml. Targets mechanism of improved exercise capacity.'}, {'measure': 'Change From Baseline to Week 12 in Quadriceps Skeletal Muscle Triglyceride Content, as Measured by % Triglycerides', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline quadriceps Skeletal Muscle Triglyceride Content at week 12 as measured by % triglycerides.'}, {'measure': 'Change From Baseline to Week 12 in Quadriceps Skeletal Muscle Fatigue, as Measured by Total Time to Muscle Fatigue During the Muscle Strength and Function Test', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline quadriceps Skeletal Muscle Fatigue at week 12 as measured by total time to muscle fatigue during the muscle strength and function test.'}, {'measure': 'Change From Baseline to Week 12 in Quadriceps Skeletal Muscle Strength During the Muscle Strength and Function Test, as Measured by Maximum Contraction Strength', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline quadriceps Skeletal Muscle Strength during the Muscle Strength and Function Test at week 12 as measured by maximum contraction strength.'}, {'measure': 'Change From Baseline to Week 12 in Quadriceps Skeletal Muscle Contractile Tissue Cross-sectional', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in quadriceps skeletal muscle contractile tissue cross-sectional at week 12 as measured by the relative change in the maximum cross-sectional area of muscle tissue of the quadriceps muscle group, measured in the axial anatomical plane.'}, {'measure': 'Change From Baseline to Week 12 in RV Myocardial Muscle Triglyceride Content, as Measured by % Triglycerides', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in right ventricle Myocardial Muscle Triglyceride Content results at week 12 as measured by % triglycerides.'}, {'measure': 'Change From Baseline to Week 12 in Tricuspid Annular Plane Systolic Excursion (TAPSE), Expressed in mm.', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in Tricuspid Annular Plane systolic Excursion (TAPSE) expressed in mm on echocardiogram results at week 12.'}, {'measure': 'Change From Baseline in Right Ventricle (RV) and Left Ventricle (LV) Ejection Fraction Values as Assessed by Echocardiogram Results, Expressed in Percentage (%).', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in RV and Left Ventricle (LV) Ejection Fraction values on echocardiogram results at week 12 and expressed in percentage (%).'}, {'measure': 'Change From Baseline in Right Ventricle (RV) Fractional Area, as Assessed by Echocardiogram Results, Expressed in Percentage (%).', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in right ventricle Fractional Area on echocardiogram results at week 12 and expressed in percentage (%).'}, {'measure': "Change From Baseline in Tricuspid Annular Velocity (S'), as Assessed by Echocardiogram Results, Expressed in cm/Sec", 'timeFrame': 'baseline and end of 12 weeks', 'description': "Change from baseline in Tricuspid Annular Velocity (S') on echocardiogram results at week 12 and expressed in cm/sec."}, {'measure': 'Change From Baseline in Tricuspid Regurgitant (TR) Velocity, as Assessed by Echocardiogram Results, Expressed in m/Sec.', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in Tricuspid Regurgitant (TR) Velocity on echocardiogram results at week 12 and expressed in m/sec.'}, {'measure': 'Change From Baseline in Estimated Right Ventricle (RV) and Right Atrial (RA) Pressure, as Assessed by Echocardiogram Results, Expressed in mmHg', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in the estimated right ventricle and right atrial pressure on echocardiogram results at week 12 and expressed in mmHg.'}, {'measure': 'Change From Baseline in Right Ventricle (RV) and Left Ventricle (LV) Diastolic Function as Assessed by Doppler Inflow Patterns on Echocardiogram.', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in right and left ventricular diastolic function as assessed by Doppler inflow patterns on echocardiogram results at week 12'}, {'measure': 'Change From Baseline in Right Ventricle (RV) Free Wall Longitudinal Strain, as Assessed by Echocardiogram Results, and Expressed as Percent (%) Change in Myocardial Deformation.', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in right ventricle free wall longitudinal strain on echocardiogram results at week 12 and expressed as percent (%) change in myocardial deformation.'}, {'measure': 'Number of Participants With a Change in Screening Clinical Characteristics', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'To compare and define the screening clinical characteristics of responders and non-responders to mHealth intervention or no intervention and/or metformin at week 12. We will be taking into account all patient screening data including demographic information, medical history, current medication regimen, physical exam, 6MWT, echocardiogram, MRS, skeletal muscle function test, emphasis-10 survey, WHO functional class, and laboratory values. These results will be aggregated and the results compared to the same characteristics at the end of week 12.\n\nWe will be assessing the number of participants with a change in screening clinical characteristics.'}, {'measure': 'Number of Patients With Treatment - Emergent Adverse Events (Safety and Tolerability of mHealth Intervention and Drug Treatment in PAH Subjects)', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Number of treatment-related adverse events as assessed by telephone calls at baseline, week one, week three, week nine, week twelve, and week seventeen.'}, {'measure': 'Patient Satisfaction of Treatment Interventions, as Measured by Change in Emphasis-10 Survey Score', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'We will be assessing patient satisfaction of treatment interventions by looking at the number of participants with an increase or decrease in overall score on the emphasis-10 questionnaire from screening and at the end of 12 weeks.\n\nThe emPHasis-10 is a short and easy questionnaire that consists of 10 items which address breathlessness, fatigue, control and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. EmPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life.'}, {'measure': 'Dropout Rate Incidence', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'To assess the effect of a mHealth intervention or no intervention and/or metformin or placebo on dropout rates over 12 weeks.'}, {'measure': 'Number of Patients With a PAH-related Hospitalization Incidence', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'To assess the effect of a mHealth intervention or no intervention and/or metformin or placebo on PAH-related hospitalization incidences over 12 weeks. Number of patients will be assessed.'}, {'measure': 'Change From Baseline to Week 12 in Patient Medication Regimen, as Measured by Percentage (%) of Subjects With a Change in Medication Regimen', 'timeFrame': 'baseline and end of 12 weeks', 'description': 'Change from baseline in patient medication regimen at week 12 as measured by percentage (%) of subjects with a change in medication regimen.'}, {'measure': 'Incidence of Death', 'timeFrame': 'baseline to/and 12 weeks', 'description': 'To assess the effect of a mHealth intervention or no intervention and/or metformin or placebo on incidence of death over 12 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PAH'], 'conditions': ['Pulmonary Artery Hypertension']}, 'referencesModule': {'references': [{'pmid': '1863023', 'type': 'BACKGROUND', 'citation': "D'Alonzo GE, Barst RJ, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, Fishman AP, Goldring RM, Groves BM, Kernis JT, et al. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med. 1991 Sep 1;115(5):343-9. doi: 10.7326/0003-4819-115-5-343."}, {'pmid': '22281797', 'type': 'BACKGROUND', 'citation': 'Benza RL, Miller DP, Barst RJ, Badesch DB, Frost AE, McGoon MD. An evaluation of long-term survival from time of diagnosis in pulmonary arterial hypertension from the REVEAL Registry. Chest. 2012 Aug;142(2):448-456. doi: 10.1378/chest.11-1460.'}, {'pmid': '22723290', 'type': 'BACKGROUND', 'citation': 'Mathai SC, Puhan MA, Lam D, Wise RA. The minimal important difference in the 6-minute walk test for patients with pulmonary arterial hypertension. Am J Respir Crit Care Med. 2012 Sep 1;186(5):428-33. doi: 10.1164/rccm.201203-0480OC. Epub 2012 Jun 21.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine the impact of two interventions against insulin resistance on the composite endpoint of 10% improvement in baseline six minute walk distance or improvement in World Health Organization (WHO) functional class in humans with pulmonary artery hypertension (PAH).', 'detailedDescription': 'The investigators propose to test the hypothesis that interventions to improve insulin resistance will improve exercise capacity and World Health Organization (WHO) functional class in PAH. The investigators propose three specific aims to test this 1) A prospective 2x2 factorial design 12-week clinical trial of metformin or placebo and activity intervention or usual care to assess effect on six minute walk and WHO functional class, 2) Assessment of the interventions in Aim 1 in a subset of patients on right ventricle (RV) and peripheral muscle function and lipid content and markers of pulmonary vascular disease to define how these interventions may work in PAH and 3) Identify and prospectively test peripheral blood markers of metformin response in PAH. The broad goals of this work are to demonstrate the efficacy and mechanisms of interventions against insulin resistance in PAH and to identify which patients are most likely to benefit from these interventions, moving to precision medicine in PAH.\n\nThe investigators are planning a factorial design trial. Patients will be randomized twice. The first is metformin or placebo and is quadruple randomized. The second is mobile health (mHealth) intervention via texts or standard of care and is not blinded to the patients, but is to the investigator and thus is triple randomized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:• Adults aged 18 or older.\n\n* Diagnosed with idiopathic, heritable, or drug- or toxin-associated pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations.\n* Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed.\n* Subjects must own a Bluetooth capable modern smartphone capable of receiving and sending text messages and an active data plan.\n* WHO Functional Class I-III\n* Ambulatory\n\nExclusion Criteria:\n\n* Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity\n* Pregnancy\n* Diagnosis of PAH etiology other than idiopathic, heritable, or associated with drugs or toxins\n* FEV1\\> or = 65% predicted AND normal chest imaging\n* WHO Functional class IV heart failure\n* Requirement of \\> 1 diuretic adjustment in the prior 30 days\n* Preferred form of activity is not measured by an activity tracker (swimming, ice skating, stair master, or activities on wheels such as bicycling or rollerblading)\n* Type I diabetes mellitus\n* Prior diagnosis of cirrhosis\n* Untreated hypo- or hyper-thyroidism\n* estimated glomerular filtration rate (eGFR) by modification of diet in renal disease (MDRD) \\<60 milliliters per minute (mL/min)'}, 'identificationModule': {'nctId': 'NCT03617458', 'briefTitle': 'Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension', 'orgStudyIdInfo': {'id': '180198'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin + mHealth Intervention', 'description': 'Patients will receive active ingredient medicine with mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.\n\nSubjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po twice a day (BID) x 5 days, 500mg by mouth (po) three times a day (TID) x 5 days,1000mg po BID x 69 days (12 weeks total).', 'interventionNames': ['Drug: Metformin', 'Device: mHealth Intervention']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + Usual Care', 'description': 'Patient will receive non active medicine and routine medical care.', 'interventionNames': ['Drug: Placebo', 'Device: Usual Care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Metformin + Usual Care', 'description': 'Patient will receive active ingredient medicine with routine medical care.\n\nSubjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po BID x 5 days, 500mg po TID x 5 days,1000mg po BID x 69 days (12 weeks total).', 'interventionNames': ['Drug: Metformin', 'Device: Usual Care']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo + mHealth Intervention', 'description': 'Patient will receive non active medicine and the mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.', 'interventionNames': ['Drug: Placebo', 'Device: mHealth Intervention']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'description': 'Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2.', 'armGroupLabels': ['Metformin + Usual Care', 'Metformin + mHealth Intervention']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'A treatment with no active ingredients or therapeutic effect.', 'armGroupLabels': ['Placebo + Usual Care', 'Placebo + mHealth Intervention']}, {'name': 'mHealth Intervention', 'type': 'DEVICE', 'description': "Our Health Insurance Portability and Accountability Act (HIPAA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.Subjects assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.", 'armGroupLabels': ['Metformin + mHealth Intervention', 'Placebo + mHealth Intervention']}, {'name': 'Usual Care', 'type': 'DEVICE', 'description': "Our HIPAA data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.", 'armGroupLabels': ['Metformin + Usual Care', 'Placebo + Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Anna R Hemnes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mayo Clinic', 'class': 'OTHER'}, {'name': 'The Cleveland Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Anna Hemnes', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}