Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-31 @ 5:08 AM
Study NCT ID:
NCT02717832
Status:
COMPLETED
Last Update Posted:
2022-05-11
First Post:
2016-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Protection Against Insulin Resistance in Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeffhoro@umich.edu', 'phone': '734-647-1076', 'title': 'Dr. Jeffrey Horowitz', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 day', 'eventGroups': [{'id': 'EG000', 'title': 'Insulin Sensitivity', 'description': 'hyperinsulinemic-euglycemic clamp', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Insulin Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Insulin Sensitivity Group', 'description': 'Adults with obesity with a rate of glucose disappearance from plasma (Rd Glucose) \\< 400 nmol/kg fat free mass/min/(uU/ml Insulin)'}, {'id': 'OG001', 'title': 'High Insulin Sensitivity Group', 'description': 'Adults with obesity with a rate of glucose disappearance from plasma (Rd Glucose) \\>550 nmol/kg fat free mass/min/(uU/ml Insulin)'}], 'classes': [{'categories': [{'measurements': [{'value': '273', 'spread': '54', 'groupId': 'OG000'}, {'value': '817', 'spread': '257', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (this cross-sectional study involves only one insulin sensitivity measurement in a single visit for each participant)', 'description': 'A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity', 'unitOfMeasure': 'nmol/kg FFM/min /(µU/mL Insulin)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'BMI: 30-40 kg/m2; waist circumference: 88-98cm for women and 100-110cm for men), age: 18-45 years old), weight stable (±3kg for ≥ 6 months), No medications known to affect lipid or glucose metabolism. No evidence and/or history of cardiovascular or metabolic diseases All women were pre-menopausal with regularly occurring menses.'}, {'type': 'SECONDARY', 'title': 'Resting Metabolic Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Insulin Sensitivity Group', 'description': 'Adults with obesity with a rate of glucose disappearance from plasma (Rd Glucose) \\< 400 nmol/kg fat free mass/min/(uU/ml Insulin)'}, {'id': 'OG001', 'title': 'High Insulin Sensitivity Group', 'description': 'Adults with obesity with a rate of glucose disappearance from plasma (Rd Glucose) \\>550 nmol/kg fat free mass/min/(uU/ml Insulin)'}], 'classes': [{'categories': [{'measurements': [{'value': '1509', 'spread': '237', 'groupId': 'OG000'}, {'value': '1325', 'spread': '198', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline (this cross-sectional study involves only one Resting Metabolic Rate measurement in a single visit for each participant)', 'description': 'Resting metabolic rate was measured using a metabolic cart (to measure VO2 and VCO2) in the morning after an overnight fast', 'unitOfMeasure': 'kcals/day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'BMI: 30-40 kg/m2; waist circumference: 88-98cm for women and 100-110cm for men), age: 18-45 years old), weight stable (±3kg for ≥ 6 months), No medications known to affect lipid or glucose metabolism. No evidence and/or history of cardiovascular or metabolic diseases All women were pre-menopausal with regularly occurring menses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Insulin Sensitivity', 'description': 'hyperinsulinemic-euglycemic clamp'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Inability to place IV', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Insulin Sensitivity', 'description': 'hyperinsulinemic-euglycemic clamp'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-21', 'size': 434540, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-08T10:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-09', 'studyFirstSubmitDate': '2016-03-07', 'resultsFirstSubmitDate': '2022-04-08', 'studyFirstSubmitQcDate': '2016-03-23', 'lastUpdatePostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-09', 'studyFirstPostDateStruct': {'date': '2016-03-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Sensitivity', 'timeFrame': 'baseline (this cross-sectional study involves only one insulin sensitivity measurement in a single visit for each participant)', 'description': 'A hyperinsulinemic-euglycemic clamp will be used to assess peripheral insulin sensitivity'}], 'secondaryOutcomes': [{'measure': 'Resting Metabolic Rate', 'timeFrame': 'baseline (this cross-sectional study involves only one Resting Metabolic Rate measurement in a single visit for each participant)', 'description': 'Resting metabolic rate was measured using a metabolic cart (to measure VO2 and VCO2) in the morning after an overnight fast'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'The overall goal of this project is to identify factors that "protect" some obese adults from becoming insulin resistant. Identifying mechanisms that help protect some obese adults from developing insulin resistance could lead to novel, targeted therapeutic and/or preventative strategies for obese adults who are insulin resistant.', 'detailedDescription': 'SCREENING PROCEDURES Participants will undergo a battery of initial screening tests including: a detailed health history and physical examination, a physical activity questionnaire, and a body composition assessment. All women will undergo a urine pregnancy test.\n\nGENERAL STUDY DESIGN To avoid potential confounding hormonal effects, all women will be studied in the early follicular phase of their menstrual cycle. Subjects will be advised of what they should be eating in the 3 days leading up to their hospital visit to maintain their weight. Subjects will also complete a three day food journal before their hospital visit. The day prior to the study trial admission, subjects will need to eat pre-prepared standardized meals for breakfast, lunch, dinner and an evening snack that the study team has given them.\n\nSubjects will be admitted to the Michigan Clinical Research Unit (MCRU) in the morning after a 12-hour, overnight fast. After arrival, subjects will rest quietly in their room for about 30 minutes. The study team will then measure subjects resting metabolic rate for about 20 minutes. After this test, an intravenous (IV) catheter will be placed for infusions and a second IV will be placed in vein of the opposite arm for blood sampling.\n\nAfter the IV placement, the study team will begin a tracer-labeled glucose, or "sugar," infusion. The study team will then remove a small sample of muscle from the subjects thigh. This muscle biopsy procedure involves numbing a nickel-sized portion of the skin of the thigh with a local anesthetic, making a small incision (1/4 inch), and removing a small piece of muscle (approximately the size of 2-3 grains of rice). The incision will then be closed with a piece of sterile tape. The study team will also obtain a small sample of fat tissue from the area just underneath the skin near the belly button. This procedure involves numbing a small region of skin near the belly button with a local anesthetic, using a needle a small amount of fat tissue is removed from underneath the skin. During the procedure subjects will feel some pinching and pulling, but it should not be very painful. The injury resulting from the muscle and fat tissue biopsies is rather minor. Subjects will likely have some bruising and mild soreness, but it should not prevent them from performing their general daily activities.\n\nApproximately 2.5 hours after admission, the study team will begin the tracer-labeled fat infusion. The tracer-labeled fats the study team are infusing occur naturally in the body. By injecting a slightly greater amount of this substance than what is already in the body the study team will be able to measure the rate of fat breakdown and fat burning. After about 50 minutes of the infusion, three blood samples will be obtained in 5 min intervals.\n\nAfter, the study team will begin a hyperinsulinemic-euglycemic clamp procedure (a procedure to measure the body\'s sensitivity to insulin). During this procedure the study team will infuse insulin and glucose through the IV and will collect blood samples every 5 minutes for the duration of the procedure to monitor the subjects blood glucose and blood insulin concentrations. This procedure is designed to last 2 hours. The study team will change the infusion rate of glucose accordingly to ensure that the subjects blood sugar is maintained at a healthy/normal level. The study team will also infuse a small amount of potassium to make sure potassium concentrations remain at healthy/normal levels. About 30 minutes after starting this procedure to measure the body\'s sensitivity to insulin, the study team will collect another sample of muscle from the thigh and fat tissue from the area just underneath the skin near the belly button. After completing the hyperinsulinemic-euglycemic clamp procedure, subjects will be provided a meal, and the study team will continue to monitor the subjects blood glucose concentration until stable.\n\nWhen the subjects vital signs are stable, the study team will also measure percent body fat using a Dual Energy X-ray Absorptiometry (DEXA) and intra-abdominal fat by Magnetic resonance imaging (MRI). When the DEXA scan and MRI tests have been completed, subjects will be discharged from the hospital. Depending on scheduling, however, the DEXA scan and MRI tests may be performed on a separate occasion from the study trial admission.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index \\[BMI\\]: 30-40 kg/m2\n* Age: 18-45 years\n* All women must be pre-menopausal\n* Non-exerciser: no regularly planned exercise/physical activity\n\nExclusion Criteria:\n\n* Weight instability ≥ ±3kg ≥ 6 months\n* Medications known to affect lipid and/or glucose metabolism\n* Pregnancy or actively breast feeding'}, 'identificationModule': {'nctId': 'NCT02717832', 'acronym': 'PAIR', 'briefTitle': 'Protection Against Insulin Resistance in Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Protection Against Insulin Resistance in Obesity', 'orgStudyIdInfo': {'id': 'HUM00111275'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Insulin Sensitivity', 'interventionNames': ['Drug: hyperinsulinemic-euglycemic clamp']}], 'interventions': [{'name': 'hyperinsulinemic-euglycemic clamp', 'type': 'DRUG', 'armGroupLabels': ['Insulin Sensitivity']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Jeffrey F Horowitz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Movement Science and Director, Substrate Metabolism Laboratory', 'investigatorFullName': 'Jeffrey F Horowitz', 'investigatorAffiliation': 'University of Michigan'}}}}