Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-01-26 @ 6:54 AM
Study NCT ID:
NCT02043405
Status:
COMPLETED
Last Update Posted:
2022-04-25
First Post:
2014-01-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Weight Loss and/or Exercise Training to Discover Muscle Lipids Related to Insulin Sensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D018149', 'term': 'Glucose Intolerance'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006943', 'term': 'Hyperglycemia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2015-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-21', 'studyFirstSubmitDate': '2014-01-16', 'studyFirstSubmitQcDate': '2014-01-21', 'lastUpdatePostDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in insulin sensitivity', 'timeFrame': 'baseline and 3 months', 'description': 'Change in insulin sensitivity measured before and after the 3 month weight loss and exercise training intervention'}], 'secondaryOutcomes': [{'measure': 'Change in membrane localized diacylglycerol species', 'timeFrame': 'baseline and 3 months', 'description': 'Change in concentration of membrane and cytosolic diacylglycerol species before and after the intervention. Diacylglycerol is a lipid known to be related to insulin resistance.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes', 'Pre-diabetes']}, 'referencesModule': {'references': [{'pmid': '37186949', 'type': 'DERIVED', 'citation': 'Zarini S, Zemski Berry KA, Kahn DE, Garfield A, Perreault L, Kerege A, Bergman BC. Deoxysphingolipids: Atypical Skeletal Muscle Lipids Related to Insulin Resistance in Humans That Decrease Insulin Sensitivity In Vitro. Diabetes. 2023 Jul 1;72(7):884-897. doi: 10.2337/db22-1018.'}]}, 'descriptionModule': {'briefSummary': 'The investigators will use exercise training and weight loss to discover localized lipid species related to diabetes risk in people.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese men and women with pre-diabetes; (BMI 30-40 kg/m2)\n* Ages ranging from 30-60 years old;\n* Individuals with:\n\n * impaired fasting glucose (IFG), (between 100-125mg/dl, with post-prandial glucose (\\<140 mg/dl 2 hrs after 75g OGTT)\n * impaired glucose tolerance (IGT), (normal fasting glucose \\<100mg/dl, with post-prandial glucose (\\>140 mg/dl 2 hrs after 75g OGTT)\n * a combination of the two (IFG/IGT) (both impaired fasting glucose (100-125mg/dl), and impaired glucose tolerance (\\>140 mg/dl 2 hrs after 75g OGTT), will be verified using oral glucose tolerance testing at initial screening, and\n* Sedentary (\\<2 hours/week of planned physical activity).\n\nTo increase generalizability, and because each subject serves as their own control, women will be enrolled regardless of menopausal status, use of hormone replacement therapy and oral contraceptives.\n\nExclusion Criteria:\n\n* Regular exercise more than 2 hours/week,\n* medications that could affect glucose,\n* lipid metabolism,\n* thyroid disease,\n* history of lung disease,\n* pregnancy,\n* active cigarette smoking or exposure to second hand smoke, and\n* Severe plasma lipid disorders.'}, 'identificationModule': {'nctId': 'NCT02043405', 'briefTitle': 'Weight Loss and/or Exercise Training to Discover Muscle Lipids Related to Insulin Sensitivity', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Weight Loss and/or Exercise Training to Discover Muscle Lipids Related to Insulin Sensitivity.', 'orgStudyIdInfo': {'id': '13-1551'}, 'secondaryIdInfos': [{'id': 'UL1TR001082', 'link': 'https://reporter.nih.gov/quickSearch/UL1TR001082', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exercise Training and Weight Loss Intervention', 'description': 'Combination weight loss/exercise training, on insulin sensitivity, muscle lipid composition and localization in skeletal muscle.', 'interventionNames': ['Behavioral: Weight loss and exercise training intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4 Month Weight Loss Only Intervention', 'description': 'Use exercise training and weight loss as separate interventions in obese subjects with and without pre-diabetes.', 'interventionNames': ['Behavioral: Weight loss Only Intervention']}], 'interventions': [{'name': 'Weight loss and exercise training intervention', 'type': 'BEHAVIORAL', 'description': 'Combined weight loss and exercise training intervention', 'armGroupLabels': ['Exercise Training and Weight Loss Intervention']}, {'name': 'Weight loss Only Intervention', 'type': 'BEHAVIORAL', 'description': 'Weight loss Only Intervention', 'armGroupLabels': ['4 Month Weight Loss Only Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Bryan Bergman, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Diabetes Association', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}