Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-28 @ 8:19 AM
Study NCT ID:
NCT03072602
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2017-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Racial Differences in the Natriuretic Peptide Response to Glucose Challenge
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'parora@uabmc.edu', 'phone': '12059754720', 'title': 'Dr. Pankaj Arora', 'organization': 'UNIVERSITY OF ALABAMA AT BIRMINGHAM'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '5 days', 'eventGroups': [{'id': 'EG000', 'title': 'African American', 'description': "Healthy self-identified African American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On the 4th day, participants will come to the clinic in a fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.\n\nStudy diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).\n\nGlucose Challenge: Participants will come in a fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for the next 8 hours.", 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'White', 'description': "Healthy self-identified White participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On the 4th day, participants will come to the clinic in a fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.\n\nStudy diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).\n\nGlucose Challenge: Participants will come in a fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for the next 8 hours.", 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plasma MRproANP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'African-American', 'description': "Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.\n\nStudy diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).\n\nGlucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours."}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '27'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days', 'description': 'Change in circulating MRproANP levels in response to glucose challenge in African-Americans (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log MRproANP with 95% CI)', 'unitOfMeasure': 'Percentage of change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Difference in Circulating Plasma MRproANP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African-American', 'description': "Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.\n\nStudy diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).\n\nGlucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours."}, {'id': 'OG001', 'title': 'Whites', 'description': "Healthy self-identified white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.\n\nStudy diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).\n\nGlucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours."}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000', 'lowerLimit': '19', 'upperLimit': '27'}, {'value': '34', 'groupId': 'OG001', 'lowerLimit': '31', 'upperLimit': '38'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days', 'description': 'Change in circulating MRproANP levels in response to glucose challenge between African-Americans and whites (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log MRproANP with 95% CI)', 'unitOfMeasure': 'Percentage change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Insulin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African-American', 'description': "Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.\n\nStudy diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).\n\nGlucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours."}, {'id': 'OG001', 'title': 'Whites', 'description': "Healthy self-identified white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.\n\nStudy diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).\n\nGlucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours."}], 'classes': [{'categories': [{'measurements': [{'value': '98.5', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '69.7', 'spread': '6.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1 hour after glucose challenge', 'description': 'The difference in serum insulin levels at 1 hour in response to glucose challenge between African-Americans and whites', 'unitOfMeasure': 'µU/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African-American', 'description': "Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.\n\nStudy diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).\n\nGlucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours."}, {'id': 'OG001', 'title': 'Whites', 'description': "Healthy self-identified white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.\n\nStudy diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).\n\nGlucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours."}], 'classes': [{'categories': [{'measurements': [{'value': '129.9', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '126.8', 'spread': '6.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 1 hour after glucose challenge', 'description': 'The difference in serum glucose levels at 1 hour in response to glucose challenge between African-Americans and whites', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plasma NTproBNP', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African-American', 'description': "Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.\n\nStudy diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).\n\nGlucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours."}, {'id': 'OG001', 'title': 'Whites', 'description': "Healthy self-identified white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.\n\nStudy diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).\n\nGlucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours."}], 'classes': [{'categories': [{'measurements': [{'value': '-1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '-3', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days', 'description': 'Change in circulating NTproBNP levels in response to glucose challenge in African-Americans and Whites (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log NTproBNP with 95% CI)', 'unitOfMeasure': 'Percentage', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Neprilysin (Membrane Metalloendopeptidase) mRNA Expression Levels Between African-Americans and Whites', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'African American', 'description': "Healthy self-identified African American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On the 4th day, participants will come to the clinic in a fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.\n\nStudy diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).\n\nGlucose Challenge: Participants will come in a fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for the next 8 hours."}, {'id': 'OG001', 'title': 'White', 'description': "Healthy self-identified White participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On the 4th day, participants will come to the clinic in a fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.\n\nStudy diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).\n\nGlucose Challenge: Participants will come in a fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for the next 8 hours."}], 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '0.79', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline', 'description': 'The relative circulating Neprilysin (Membrane Metalloendopeptidase) mRNA quantification (fold change) at baseline between African-Americans and Whites', 'unitOfMeasure': 'fold change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'African American', 'description': "Healthy self-identified African American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On the 4th day, participants will come to the clinic in a fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.\n\nStudy diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).\n\nGlucose Challenge: Participants will come in a fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for the next 8 hours."}, {'id': 'FG001', 'title': 'White', 'description': "Healthy self-identified White participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On the 4th day, participants will come to the clinic in a fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.\n\nStudy diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).\n\nGlucose Challenge: Participants will come in a fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for the next 8 hours."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': '81 participants started the study; 39 Blacks and 42 Whites', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'Total Participant Screened for the Purpose of Eligibilty', 'comment': '94 participants were screened for eligibility', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'Ineligible Participants', 'comment': '13 determined ineligible by screening labs', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Participant Received Standardized Meals', 'comment': '81 Participants received 3 days of standardized meals to control for salt intake', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '42'}]}, {'type': 'Study Dropouts', 'comment': '7 study dropouts', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Participants Returned for Glucose Challenge Protocol', 'comment': '74 participants returned for the glucose challenge protocol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'Unable to Complete the Protocol', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'comment': '72 participants completed the study; 34 Blacks and 38 Whites', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': 'A total of 81 participants agreed to participate in the study following the completion of the informed consent process and were assigned to each Arm/group. We had 7 study dropouts and 2 participants were not able to complete the protocol. A total of 72 participants completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'African-American', 'description': "Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.\n\nStudy diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).\n\nGlucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours."}, {'id': 'BG001', 'title': 'White', 'description': "Healthy self-identified white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.\n\nStudy diet: Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).\n\nGlucose Challenge: Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '33'}, {'value': '26', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '30'}, {'value': '27', 'groupId': 'BG002', 'lowerLimit': '21', 'upperLimit': '33'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}], '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'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '31'}, {'value': '25', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '27'}, {'value': '26', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '31'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Systolic Blood Pressure', 'classes': [{'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000', 'lowerLimit': '108', 'upperLimit': '124'}, {'value': '112', 'groupId': 'BG001', 'lowerLimit': '105', 'upperLimit': '118'}, {'value': '114', 'groupId': 'BG002', 'lowerLimit': '105', 'upperLimit': '124'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sodium', 'classes': [{'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000', 'lowerLimit': '138', 'upperLimit': '140'}, {'value': '139', 'groupId': 'BG001', 'lowerLimit': '137', 'upperLimit': '140'}, {'value': '139', 'groupId': 'BG002', 'lowerLimit': '137', 'upperLimit': '140'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Potassium', 'classes': [{'categories': [{'measurements': [{'value': '4.0', 'groupId': 'BG000', 'lowerLimit': '3.9', 'upperLimit': '4.3'}, {'value': '4.1', 'groupId': 'BG001', 'lowerLimit': '3.9', 'upperLimit': '4.3'}, {'value': '4.1', 'groupId': 'BG002', 'lowerLimit': '3.9', 'upperLimit': '4.3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Creatinine', 'classes': [{'categories': [{'measurements': [{'value': '0.8', 'groupId': 'BG000', 'lowerLimit': '0.8', 'upperLimit': '1.0'}, {'value': '0.8', 'groupId': 'BG001', 'lowerLimit': '0.7', 'upperLimit': '1.0'}, {'value': '0.8', 'groupId': 'BG002', 'lowerLimit': '0.7', 'upperLimit': '1.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Percentage of Hematocrit', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000', 'lowerLimit': '37', 'upperLimit': '43'}, {'value': '40', 'groupId': 'BG001', 'lowerLimit': '39', 'upperLimit': '43'}, {'value': '40', 'groupId': 'BG002', 'lowerLimit': '37', 'upperLimit': '43'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': '%', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Fasting Glucose', 'classes': [{'categories': [{'measurements': [{'value': '93.7', 'spread': '11.6', 'groupId': 'BG000'}, {'value': '93.1', 'spread': '5.8', 'groupId': 'BG001'}, {'value': '93.4', 'spread': '9.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Insulin', 'classes': [{'categories': [{'measurements': [{'value': '14.3', 'spread': '18.4', 'groupId': 'BG000'}, {'value': '6.6', 'spread': '3.6', 'groupId': 'BG001'}, {'value': '10.2', 'spread': '13.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)', 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '5.8', 'groupId': 'BG000'}, {'value': '1.5', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '2.5', 'spread': '4.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'HOMA-IR is used to estimate insulin resistance. HOMA-IR = Fasting insulin levels in mU/l X Fasting glucose levels in mg/dl/405. The normal HOMA-IR value in healthy humans ranges from 0.5-1.4. The HOMA-IR value greater than 2.5 indicates significant insulin resistance. The HOMA-IR above 1.9 indicates early insulin resistance.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Mid-regional pro-atrial natriuretic peptide (MRproANP)', 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000', 'lowerLimit': '33', 'upperLimit': '55'}, {'value': '52', 'groupId': 'BG001', 'lowerLimit': '45', 'upperLimit': '65'}, {'value': '48', 'groupId': 'BG002', 'lowerLimit': '33', 'upperLimit': '65'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pmol/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'B-type natriuretic peptide (BNP)', 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000', 'lowerLimit': '13', 'upperLimit': '23'}, {'value': '22', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '33'}, {'value': '20', 'groupId': 'BG002', 'lowerLimit': '13', 'upperLimit': '33'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'N-terminal pro-B-type natriuretic peptide (NTproBNP)', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000', 'lowerLimit': '14', 'upperLimit': '23'}, {'value': '33', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '53'}, {'value': '24', 'groupId': 'BG002', 'lowerLimit': '14', 'upperLimit': '53'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-20', 'size': 369962, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-05-28T19:32', 'hasProtocol': True}, {'date': '2019-07-27', 'size': 192738, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-10-04T11:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Each participant will be enrolled into one of the two groups by race.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-15', 'studyFirstSubmitDate': '2017-02-27', 'resultsFirstSubmitDate': '2021-05-28', 'studyFirstSubmitQcDate': '2017-03-02', 'lastUpdatePostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-08-27', 'studyFirstPostDateStruct': {'date': '2017-03-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma MRproANP', 'timeFrame': 'From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days', 'description': 'Change in circulating MRproANP levels in response to glucose challenge in African-Americans (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log MRproANP with 95% CI)'}], 'secondaryOutcomes': [{'measure': 'The Difference in Circulating Plasma MRproANP', 'timeFrame': 'From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days', 'description': 'Change in circulating MRproANP levels in response to glucose challenge between African-Americans and whites (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log MRproANP with 95% CI)'}, {'measure': 'Serum Insulin', 'timeFrame': 'At 1 hour after glucose challenge', 'description': 'The difference in serum insulin levels at 1 hour in response to glucose challenge between African-Americans and whites'}, {'measure': 'Serum Glucose', 'timeFrame': 'At 1 hour after glucose challenge', 'description': 'The difference in serum glucose levels at 1 hour in response to glucose challenge between African-Americans and whites'}, {'measure': 'Plasma NTproBNP', 'timeFrame': 'From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days', 'description': 'Change in circulating NTproBNP levels in response to glucose challenge in African-Americans and Whites (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log NTproBNP with 95% CI)'}, {'measure': 'Change in Neprilysin (Membrane Metalloendopeptidase) mRNA Expression Levels Between African-Americans and Whites', 'timeFrame': 'At baseline', 'description': 'The relative circulating Neprilysin (Membrane Metalloendopeptidase) mRNA quantification (fold change) at baseline between African-Americans and Whites'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Racial differences'], 'conditions': ['Healthy', 'Natriuretic Peptides', 'Metabolic Syndrome']}, 'referencesModule': {'references': [{'pmid': '26892417', 'type': 'BACKGROUND', 'citation': 'Arora P, Wu C, Hamid T, Arora G, Agha O, Allen K, Tainsh RET, Hu D, Ryan RA, Domian IJ, Buys ES, Bloch DB, Prabhu SD, Bloch KD, Newton-Cheh C, Wang TJ. Acute Metabolic Influences on the Natriuretic Peptide System in Humans. J Am Coll Cardiol. 2016 Feb 23;67(7):804-812. doi: 10.1016/j.jacc.2015.11.049.'}, {'pmid': '25595796', 'type': 'BACKGROUND', 'citation': 'Arora P, Reingold J, Baggish A, Guanaga DP, Wu C, Ghorbani A, Song Y, Chen-Tournaux A, Khan AM, Tainsh LT, Buys ES, Williams JS, Heublein DM, Burnett JC, Semigran MJ, Bloch KD, Scherrer-Crosbie M, Newton-Cheh C, Kaplan LM, Wang TJ. Weight loss, saline loading, and the natriuretic peptide system. J Am Heart Assoc. 2015 Jan 16;4(1):e001265. doi: 10.1161/JAHA.114.001265.'}, {'pmid': '27185878', 'type': 'BACKGROUND', 'citation': 'Wu C, Arora P, Agha O, Hurst LA, Allen K, Nathan DI, Hu D, Jiramongkolchai P, Smith JG, Melander O, Trenson S, Janssens SP, Domian I, Wang TJ, Bloch KD, Buys ES, Bloch DB, Newton-Cheh C. Novel MicroRNA Regulators of Atrial Natriuretic Peptide Production. Mol Cell Biol. 2016 Jun 29;36(14):1977-87. doi: 10.1128/MCB.01114-15. Print 2016 Jul 15.'}, {'pmid': '31588864', 'type': 'RESULT', 'citation': 'Patel N, Russell GK, Musunuru K, Gutierrez OM, Halade G, Kain V, Lv W, Prabhu SD, Margulies KB, Cappola TP, Arora G, Wang TJ, Arora P. Race, Natriuretic Peptides, and High-Carbohydrate Challenge: A Clinical Trial. Circ Res. 2019 Nov 8;125(11):957-968. doi: 10.1161/CIRCRESAHA.119.315026. Epub 2019 Oct 6.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to discover any racial dissimilarity in the response of Natriuretic peptide (NP) system to acute metabolic influences such as a high carbohydrate challenge', 'detailedDescription': 'Previous studies have shown an association between reduced levels of circulating natriuretic peptides (NPs) and obesity in humans. This association is especially pronounced in those with metabolic syndrome traits and elevated plasma insulin. As previously conducted study has shown that an increase in NPs with weight loss in obese individuals is "primary" and not secondary to alteration in cardiac structure or function.\n\nPrevious experimental data suggests that Atrial NP (ANP) has a wide range of favorable metabolic effects including that activation of brown fat and improvement in skeletal muscle oxidative capacity and glucose utilization. New evidence suggests that ANP activation directly modulates insulin sensitivity and energy homeostasis, suggesting that ANP suppression could promote more obesity/insulin resistance. Moreover, ANP exerts potent lipolytic effects in vitro and in vivo. The previous study has shown that a high-carbohydrate challenge in healthy volunteers is associated with a reduction in N-terminal-proANP (NTproANP) but not N-terminal-proB-type NP (NTproBNP) levels. Nonetheless our outcomes were predominantly in Caucasians and warrants replication in other racial groups.\n\nThere is no data on the ANP response to high-carbohydrate challenge in African Americans, a racial group with disproportionately greater rates of obesity, insulin resistance, and diabetes as compared to Caucasians. So the investigators have proposed to conduct a pilot study in otherwise healthy, normotensive subjects to examine NP system, especially the effects on MRproANP in response of high-carbohydrate challenge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-40 years\n* Blood pressure less than 140/90\n* Estimated creatinine clearance \\>60cc/min\n* Willingness to comply with the study diet\n\nExclusion Criteria:\n\n* History of hypertension\n* History of cardiovascular, renal, or liver disease\n* Diabetes or use of glucose-lowering medications\n* Use of vasoactive or diuretic medications\n* Atrial fibrillation\n* Anemia (Hematocrit \\< 41% in men and \\<35% in women\n* Abnormal serum sodium or potassium\n* Urine β-HCG consistent with pregnancy\n* Abnormal liver function tests (\\>3x upper limit of normal)\n* Women taking hormonal birth control\n* Current smokers\n* Regular users of non-steroid anti-inflammatory medications'}, 'identificationModule': {'nctId': 'NCT03072602', 'briefTitle': 'Racial Differences in the Natriuretic Peptide Response to Glucose Challenge', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'A Study of Racial Differences in Natriuretic Peptides Response to Glucose Challenge', 'orgStudyIdInfo': {'id': 'X16081002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'African-American', 'description': "Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.", 'interventionNames': ['Dietary Supplement: Study diet', 'Other: Glucose Challenge']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'White', 'description': "Healthy self-identified white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.", 'interventionNames': ['Dietary Supplement: Study diet', 'Other: Glucose Challenge']}], 'interventions': [{'name': 'Study diet', 'type': 'DIETARY_SUPPLEMENT', 'description': "Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).", 'armGroupLabels': ['African-American', 'White']}, {'name': 'Glucose Challenge', 'type': 'OTHER', 'description': 'Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.', 'armGroupLabels': ['African-American', 'White']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Pankaj Arora, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Pankaj Arora, MD', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}