Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-31 @ 7:30 PM
Study NCT ID:
NCT04055012
Status:
TERMINATED
Last Update Posted:
2025-02-21
First Post:
2019-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effects of Metformin on Low Back Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-01-07', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': 'kesslerl@upmc.edu', 'phone': '412-692-2084', 'title': 'Study Coordinator', 'organization': 'The University of Pittsburgh'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The study was halted early due to funding redirection. Due to limited sample size, formal statistical analysis for between group comparisons was not feasible, and no clear trends were established.'}}, 'adverseEventsModule': {'timeFrame': 'up to 15 months', 'eventGroups': [{'id': 'EG000', 'title': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'High Dose Placebo', 'description': 'High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.\n\nPlacebo: Placebo Tabs', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Low Dose Placebo', 'description': 'Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.\n\nPlacebo: Placebo Tabs', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abnormal Lab Value - Low Vitamin B12', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal Lab Value - Elevated ESR', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal Lab Value - Low Alkaline Phosphatase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal Lab Value - Hypoglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal Lab Value - Elevated CBC', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal Lab Value - Hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abnormal Lab Value - Elevated Potassium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Low Iron', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Acid Reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Gas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Abdominal Cramping', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Numeric Pain Rating Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG001', 'title': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG002', 'title': 'High Dose Placebo', 'description': 'High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.\n\nPlacebo: Placebo Tabs'}, {'id': 'OG003', 'title': 'Low Dose Placebo', 'description': 'Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.\n\nPlacebo: Placebo Tabs'}], 'classes': [{'title': 'change in pain score', 'categories': [{'measurements': [{'value': '-1.16', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '0.58', 'groupId': 'OG001'}, {'value': '-1.5', 'spread': '0.71', 'groupId': 'OG002'}, {'value': '0.33', 'spread': '3.06', 'groupId': 'OG003'}]}]}, {'title': 'baseline pain score', 'categories': [{'measurements': [{'value': '5.33', 'spread': '1.03', 'groupId': 'OG000'}, {'value': '5.75', 'spread': '2.22', 'groupId': 'OG001'}, {'value': '6', 'spread': '2.83', 'groupId': 'OG002'}, {'value': '2.33', 'spread': '2.08', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 15 months', 'description': 'Scores range from 0 to 10 with a higher score indicating more severe pain', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Oswestry Disability Index (ODI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG001', 'title': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG002', 'title': 'High Dose Placebo', 'description': 'High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.\n\nPlacebo: Placebo Tabs'}, {'id': 'OG003', 'title': 'Low Dose Placebo', 'description': 'Low Dose Placebo Group (n=100). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.\n\nPlacebo: Placebo Tabs'}], 'classes': [{'title': 'average ODI change', 'categories': [{'measurements': [{'value': '-3', 'spread': '7.01', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '12.37', 'groupId': 'OG001'}, {'value': '-8', 'spread': '2.83', 'groupId': 'OG002'}, {'value': '-8.67', 'spread': '10.07', 'groupId': 'OG003'}]}]}, {'title': 'baseline ODI', 'categories': [{'measurements': [{'value': '23.33', 'spread': '4.13', 'groupId': 'OG000'}, {'value': '26', 'spread': '9.38', 'groupId': 'OG001'}, {'value': '21', 'spread': '1.41', 'groupId': 'OG002'}, {'value': '20.67', 'spread': '10.26', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 15 months', 'description': 'Scores range from 0% to 100% with higher scores indicating greater disability', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BACPAC (Back Pain Consortium) Minimum Dataset: Pain Outcomes Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG001', 'title': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG002', 'title': 'High Dose Placebo', 'description': 'High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.\n\nPlacebo: Placebo Tabs'}, {'id': 'OG003', 'title': 'Low Dose Placebo', 'description': 'Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.\n\nPlacebo: Placebo Tabs'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.33', 'spread': '1.21', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1', 'groupId': 'OG001'}, {'value': '0.5', 'spread': '0.71', 'groupId': 'OG002'}, {'value': '-0.33', 'spread': '1.15', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 15 months', 'description': 'Current pain on average reported on 0-10 scale, higher scores indicate greater pain', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 10 Meter Walk Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG001', 'title': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG002', 'title': 'High Dose Placebo', 'description': 'Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.\n\nPlacebo: Placebo Tabs'}, {'id': 'OG003', 'title': 'Low Dose Placebo', 'description': 'Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.\n\nPlacebo: Placebo Tabs'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.71', 'spread': '5.26', 'groupId': 'OG000'}, {'value': '-0.57', 'spread': '1.91', 'groupId': 'OG001'}, {'value': '-0.73', 'spread': '0.47', 'groupId': 'OG002'}, {'value': '-0.05', 'spread': '1.26', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 15 months', 'description': 'Subject is timed walking at self-selected speed. A faster time (fewer seconds to complete the walk) is associated with better outcome.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Fear Avoidance Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG001', 'title': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG002', 'title': 'High Dose Placebo', 'description': 'High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.\n\nPlacebo: Placebo Tabs'}, {'id': 'OG003', 'title': 'Low Dose Placebo', 'description': 'Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.\n\nPlacebo: Placebo Tabs'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.67', 'spread': '5.20', 'groupId': 'OG000'}, {'value': '-0.25', 'spread': '8.81', 'groupId': 'OG001'}, {'value': '-7', 'spread': '4.24', 'groupId': 'OG002'}, {'value': '-5.67', 'spread': '3.79', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 15 months', 'description': 'Scores range from 0 to 96 in which a higher score indicates greater fear avoidance beliefs', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in STarT Back Tool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG001', 'title': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG002', 'title': 'High Dose Placebo', 'description': 'Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.\n\nPlacebo: Placebo Tabs'}, {'id': 'OG003', 'title': 'Low Dose Placebo', 'description': 'Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.\n\nPlacebo: Placebo Tabs'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.83', 'spread': '2.40', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.29', 'groupId': 'OG001'}, {'value': '0', 'spread': '2.83', 'groupId': 'OG002'}, {'value': '-0.33', 'spread': '3.06', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 15 months', 'description': 'Scores range from 0-9. A higher score indicates higher risk of persisting disabling symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 6-item Pain Catastrophizing Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG001', 'title': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG002', 'title': 'High Dose Placebo', 'description': 'Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.\n\nPlacebo: Placebo Tabs'}, {'id': 'OG003', 'title': 'Low Dose Placebo', 'description': 'Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.\n\nPlacebo: Placebo Tabs'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.67', 'spread': '3.88', 'groupId': 'OG000'}, {'value': '0.75', 'spread': '4.79', 'groupId': 'OG001'}, {'value': '-2', 'spread': '1.41', 'groupId': 'OG002'}, {'value': '0.33', 'spread': '3.79', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 15 months', 'description': 'Score range from 0 to 24 with a higher score indicating a higher degree of catastrophizing', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Positive Outlook v1.0 - Short Form 6a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG001', 'title': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG002', 'title': 'High Dose Placebo', 'description': 'High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.\n\nPlacebo: Placebo Tabs'}, {'id': 'OG003', 'title': 'Low Dose Placebo', 'description': 'Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.\n\nPlacebo: Placebo Tabs'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '5.78', 'groupId': 'OG000'}, {'value': '0.225', 'spread': '5.97', 'groupId': 'OG001'}, {'value': '-2.55', 'spread': '1.20', 'groupId': 'OG002'}, {'value': '-10.27', 'spread': '20.35', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 15 months', 'description': 'For most PROMIS domains, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher score indicates a more positive outlook.', 'unitOfMeasure': 'T score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG001', 'title': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG002', 'title': 'High Dose Placebo', 'description': 'High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.\n\nPlacebo: Placebo Tabs'}, {'id': 'OG003', 'title': 'Low Dose Placebo', 'description': 'Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.\n\nPlacebo: Placebo Tabs'}], 'classes': [{'title': 'Change from baseline in Physical function', 'categories': [{'measurements': [{'value': '-0.62', 'spread': '4.26', 'groupId': 'OG000'}, {'value': '-2.075', 'spread': '3.089', 'groupId': 'OG001'}, {'value': '-0.6', 'spread': '9.48', 'groupId': 'OG002'}, {'value': '-1.43', 'spread': '2.48', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline in Anxiety', 'categories': [{'measurements': [{'value': '0.55', 'spread': '5.32', 'groupId': 'OG000'}, {'value': '-3.075', 'spread': '3.27', 'groupId': 'OG001'}, {'value': '-6.75', 'spread': '1.34', 'groupId': 'OG002'}, {'value': '-6.63', 'spread': '5.75', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline in Depression', 'categories': [{'measurements': [{'value': '2.25', 'spread': '6.97', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '5.72', 'groupId': 'OG001'}, {'value': '-1.35', 'spread': '5.87', 'groupId': 'OG002'}, {'value': '-7.8', 'spread': '8.17', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline in Fatigue', 'categories': [{'measurements': [{'value': '-1.35', 'spread': '12.90', 'groupId': 'OG000'}, {'value': '-3.2', 'spread': '6.4', 'groupId': 'OG001'}, {'value': '-0.85', 'spread': '6.72', 'groupId': 'OG002'}, {'value': '0.43', 'spread': '6.36', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline in Sleep disturbance', 'categories': [{'measurements': [{'value': '1', 'spread': '4.76', 'groupId': 'OG000'}, {'value': '0.275', 'spread': '3.24', 'groupId': 'OG001'}, {'value': '-1.2', 'spread': '5.66', 'groupId': 'OG002'}, {'value': '-1.33', 'spread': '1.40', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline in Ability to participate in social roles and activities in the past 7 days', 'categories': [{'measurements': [{'value': '-3.1', 'spread': '6.44', 'groupId': 'OG000'}, {'value': '-1.575', 'spread': '9.45', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '4.95', 'groupId': 'OG002'}, {'value': '1.27', 'spread': '2.19', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline in Pain interference in the past 7 days', 'categories': [{'measurements': [{'value': '-1.55', 'spread': '3.22', 'groupId': 'OG000'}, {'value': '-4.175', 'spread': '7.40', 'groupId': 'OG001'}, {'value': '-4.8', 'spread': '1.70', 'groupId': 'OG002'}, {'value': '3.07', 'spread': '5.31', 'groupId': 'OG003'}]}]}, {'title': 'Change from baseline in Cognitive function-Abilities', 'categories': [{'measurements': [{'value': '0', 'spread': '13.28', 'groupId': 'OG000'}, {'value': '0', 'spread': '6.70', 'groupId': 'OG001'}, {'value': '-6.75', 'spread': '3.61', 'groupId': 'OG002'}, {'value': '-1.07', 'spread': '1.85', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 15 months', 'description': 'The PROMIS (Patient-Reported Outcomes Measurement Information System) 29 is a 29 question assessment of 8 domains of health related quality of life (physical function, fatigue, sleep disturbance, pain interference, anxiety, depression, ability to participate in social roles and activities, and cognitive function. For most PROMIS domains, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. Higher T scores indicates greater report of the concept being measured.', 'unitOfMeasure': 'T score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in General Self-Efficacy - Short Form 4a', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG001', 'title': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG002', 'title': 'High Dose Placebo', 'description': 'High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.\n\nPlacebo: Placebo Tabs'}, {'id': 'OG003', 'title': 'Low Dose Placebo', 'description': 'Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.\n\nPlacebo: Placebo Tabs'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.97', 'spread': '8.01', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '3.90', 'groupId': 'OG001'}, {'value': '5.45', 'spread': '7.71', 'groupId': 'OG002'}, {'value': '-8.2', 'spread': '9.63', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 15 months', 'description': 'For most PROMIS domains, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher score indicate higher self efficacy.', 'unitOfMeasure': 'T score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Global Physical Activity Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG001', 'title': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG002', 'title': 'High Dose Placebo', 'description': 'High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.\n\nPlacebo: Placebo Tabs'}, {'id': 'OG003', 'title': 'Low Dose Placebo', 'description': 'Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.\n\nPlacebo: Placebo Tabs'}], 'classes': [{'categories': [{'measurements': [{'value': '-1100', 'spread': '3325.9', 'groupId': 'OG000'}, {'value': '-1825', 'spread': '2953.0', 'groupId': 'OG001'}, {'value': '1050', 'spread': '551.54', 'groupId': 'OG002'}, {'value': '-277.33', 'spread': '240.71', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 15 months', 'description': 'This questionnaire developed by the World Health Organization measures physical activity at work or school, household, travel, recreational and sedentary behaviors, measured in MET (metabolic equivalent)-minutes per week (continuous variable).', 'unitOfMeasure': 'MET- minutes per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in McGill Pain Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG001', 'title': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG002', 'title': 'High Dose Placebo', 'description': 'High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.\n\nPlacebo: Placebo Tabs'}, {'id': 'OG003', 'title': 'Low Dose Placebo', 'description': 'Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.\n\nPlacebo: Placebo Tabs'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.83', 'spread': '3.43', 'groupId': 'OG000'}, {'value': '-2.5', 'spread': '5.80', 'groupId': 'OG001'}, {'value': '-3.5', 'spread': '2.12', 'groupId': 'OG002'}, {'value': '-11.67', 'spread': '19.86', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 15 months', 'description': 'Scores range from 0 to 45 with a higher score indicating more qualitatively severe and impactful pain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Charlson Comorbidity Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG001', 'title': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG002', 'title': 'High Dose Placebo', 'description': 'High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.\n\nPlacebo: Placebo Tabs'}, {'id': 'OG003', 'title': 'Low Dose Placebo', 'description': 'Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.\n\nPlacebo: Placebo Tabs'}], 'classes': [{'categories': [{'measurements': [{'value': '0.17', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '0.25', 'spread': '0.5', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 15 months', 'description': 'Measures overall health with a higher score more likely predicative of mortality or higher resource use. Scale is scored 0-37.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Financial Strain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG001', 'title': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'OG002', 'title': 'High Dose Placebo', 'description': 'High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.\n\nPlacebo: Placebo Tabs'}, {'id': 'OG003', 'title': 'Low Dose Placebo', 'description': 'Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.\n\nPlacebo: Placebo Tabs'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}, {'value': '0', 'spread': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 15 months', 'description': 'Measures strain of finances. Score ranges from 1-4. The lower the score the harder the financial strain.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'FG001', 'title': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'FG002', 'title': 'High Dose Placebo', 'description': 'High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.\n\nPlacebo: Placebo Tabs'}, {'id': 'FG003', 'title': 'Low Dose Placebo', 'description': 'Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.\n\nPlacebo: Placebo Tabs'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '2 participants were from wait-list control group', 'groupId': 'FG000', 'numSubjects': '8'}, {'comment': '1 participant was from wait-list control group', 'groupId': 'FG001', 'numSubjects': '8'}, {'comment': '1 participant was from wait-list control group', 'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Metformin Recall', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'BG001', 'title': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.\n\nMetformin: 500mg tabs of Metformin Extended Release'}, {'id': 'BG002', 'title': 'High Dose Placebo', 'description': 'High Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months.\n\nPlacebo: Placebo Tabs'}, {'id': 'BG003', 'title': 'Low Dose Placebo', 'description': 'Low Dose Placebo Group (n=50). Subjects will receive placebo and will be instructed to take 1 placebo tab for 6 months.\n\nPlacebo: Placebo Tabs'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49', 'spread': '16.31826321', 'groupId': 'BG000'}, {'value': '48', 'spread': '11.86155254', 'groupId': 'BG001'}, {'value': '42', 'spread': '20.82266393', 'groupId': 'BG002'}, {'value': '45', 'spread': '16.19670748', 'groupId': 'BG003'}, {'value': '47', 'spread': '14.83639367', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '22', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', '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': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '17', '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': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '23', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-05-17', 'size': 76396, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-11T14:07', 'hasProtocol': True}, {'date': '2024-12-11', 'size': 48176, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-12T09:04', 'hasProtocol': False}, {'date': '2022-05-17', 'size': 298966, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-12-09T11:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'whyStopped': 'Funding closed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2019-08-09', 'resultsFirstSubmitDate': '2024-12-13', 'studyFirstSubmitQcDate': '2019-08-09', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-31', 'studyFirstPostDateStruct': {'date': '2019-08-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Numeric Pain Rating Scale', 'timeFrame': 'Up to 15 months', 'description': 'Scores range from 0 to 10 with a higher score indicating more severe pain'}, {'measure': 'Change From Baseline in Oswestry Disability Index (ODI)', 'timeFrame': 'Up to 15 months', 'description': 'Scores range from 0% to 100% with higher scores indicating greater disability'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in BACPAC (Back Pain Consortium) Minimum Dataset: Pain Outcomes Assessment', 'timeFrame': 'Up to 15 months', 'description': 'Current pain on average reported on 0-10 scale, higher scores indicate greater pain'}, {'measure': 'Change From Baseline in 10 Meter Walk Test', 'timeFrame': 'Up to 15 months', 'description': 'Subject is timed walking at self-selected speed. A faster time (fewer seconds to complete the walk) is associated with better outcome.'}, {'measure': 'Change From Baseline in Fear Avoidance Questionnaire', 'timeFrame': 'Up to 15 months', 'description': 'Scores range from 0 to 96 in which a higher score indicates greater fear avoidance beliefs'}, {'measure': 'Change From Baseline in STarT Back Tool', 'timeFrame': 'Up to 15 months', 'description': 'Scores range from 0-9. A higher score indicates higher risk of persisting disabling symptoms.'}, {'measure': 'Change From Baseline in 6-item Pain Catastrophizing Scale', 'timeFrame': 'Up to 15 months', 'description': 'Score range from 0 to 24 with a higher score indicating a higher degree of catastrophizing'}, {'measure': 'Change From Baseline in Positive Outlook v1.0 - Short Form 6a', 'timeFrame': 'Up to 15 months', 'description': 'For most PROMIS domains, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher score indicates a more positive outlook.'}, {'measure': 'Change From Baseline in PROMIS (Patient-Reported Outcomes Measurement Information System) 29', 'timeFrame': 'Up to 15 months', 'description': 'The PROMIS (Patient-Reported Outcomes Measurement Information System) 29 is a 29 question assessment of 8 domains of health related quality of life (physical function, fatigue, sleep disturbance, pain interference, anxiety, depression, ability to participate in social roles and activities, and cognitive function. For most PROMIS domains, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. Higher T scores indicates greater report of the concept being measured.'}, {'measure': 'Change From Baseline in General Self-Efficacy - Short Form 4a', 'timeFrame': 'Up to 15 months', 'description': 'For most PROMIS domains, a score of 50 is the average for the United States general population with a standard deviation of 10 because calibration testing was performed on a large sample of the general population. A higher score indicate higher self efficacy.'}, {'measure': 'Change From Baseline in Global Physical Activity Questionnaire', 'timeFrame': 'Up to 15 months', 'description': 'This questionnaire developed by the World Health Organization measures physical activity at work or school, household, travel, recreational and sedentary behaviors, measured in MET (metabolic equivalent)-minutes per week (continuous variable).'}, {'measure': 'Change From Baseline in McGill Pain Questionnaire', 'timeFrame': 'Up to 15 months', 'description': 'Scores range from 0 to 45 with a higher score indicating more qualitatively severe and impactful pain.'}, {'measure': 'Change in Charlson Comorbidity Index', 'timeFrame': 'Up to 15 months', 'description': 'Measures overall health with a higher score more likely predicative of mortality or higher resource use. Scale is scored 0-37.'}, {'measure': 'Change From Baseline in Financial Strain', 'timeFrame': 'Up to 15 months', 'description': 'Measures strain of finances. Score ranges from 1-4. The lower the score the harder the financial strain.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Low Back Pain', 'Metformin', 'Placebo'], 'conditions': ['Low Back Pain']}, 'descriptionModule': {'briefSummary': 'The purpose of the current study is to determine the effects of metformin in non-diabetic patients with low back pain, and identify novel targets for future treatments', 'detailedDescription': 'Outcome measures were updated after the initial submission to clinicaltrials.gov. The outcomes were changed in the Institutional Review Board protocol but not updated on clinicaltrials.gov. These outcome measures have since been updated to reflect what was collected for the trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 and above\n* Diagnosed with axial low back pain (low back pain more severe than pain in other parts of the body, without radiation of pain into the lower extremities).\n* Women of child bearing potential must have a negative serum pregnancy test at baseline.\n\nExclusion Criteria:\n\n* Diagnosed with rheumatoid arthritis, lupus, other autoimmune/systemic inflammatory arthropathies\n* Progressive lower extremity weakness or numbness\n* Recent oral steroid use (within last 3 months)\n* NSAID use\n* Chronic kidney disease (eGFR \\<60)\n* Diagnosis of diabetes mellitus\n* Subjects must not be pregnant or breastfeeding, or planning to become pregnant or breastfeed during the course of the trial\n* Unable to take an oral medication in a non crushable pill form\n* Taking metformin presently or within the last 6 months\n* History of allergy to metformin\n* History of lactic acidosis\n* Severe Hepatic dysfunction\n* Currently taking a diabetic medication such as sitagliptin, saxagliptin, linagliptin, alogliptin, sitagliptin with metformin\n* Currently taking a Carbonic anhydrase inhibitor such as topiramate, zonisamide, acetazolamide, dichlorphenamide, methazolamide\n* Currently taking cimetidine'}, 'identificationModule': {'nctId': 'NCT04055012', 'briefTitle': 'Effects of Metformin on Low Back Pain', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Metformin and Beyond: Individualizing Care for Low Back Pain', 'orgStudyIdInfo': {'id': 'STUDY19010007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Dose Metformin', 'description': 'High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.', 'interventionNames': ['Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Low Dose Metformin', 'description': 'Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.', 'interventionNames': ['Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo Group (n=100). Subjects will receive placebo and will be instructed to take either 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months OR take 1 placebo tab for 6 months.', 'interventionNames': ['Drug: Placebo']}, {'type': 'OTHER', 'label': 'Wait-List Control', 'description': 'Control Group (n=100). Subjects will be told that they are in the wait-list control group. They will have a 3 month "waiting period" before they will be randomized again to a treatment group. They will be randomized to one of the previous groups.', 'interventionNames': ['Drug: Metformin', 'Drug: Placebo']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage', 'Glucophage Extended Release', 'Metformin Extended Release', 'Metformin ER'], 'description': '500mg tabs of Metformin Extended Release', 'armGroupLabels': ['High Dose Metformin', 'Low Dose Metformin', 'Wait-List Control']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Tabs', 'armGroupLabels': ['Placebo', 'Wait-List Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Kaufmann Medical Building', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15090', 'city': 'Wexford', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Wexford Spine Center', 'geoPoint': {'lat': 40.62646, 'lon': -80.05589}}], 'overallOfficials': [{'name': 'Gwendolyn Sowa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gwendolyn Sowa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor and Chair Department of Physical Medicine and Rehabilitation', 'investigatorFullName': 'Gwendolyn Sowa', 'investigatorAffiliation': 'University of Pittsburgh'}}}}