Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-09 @ 2:38 PM
Study NCT ID:
NCT00677651
Status:
COMPLETED
Last Update Posted:
2009-08-18
First Post:
2008-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sex Differences in Gene Expression in Human Adipose Tissue
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, Fat tissue from abdomen and buttock'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-08-17', 'studyFirstSubmitDate': '2008-05-12', 'studyFirstSubmitQcDate': '2008-05-12', 'lastUpdatePostDateStruct': {'date': '2009-08-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adipose and blood sampling', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'CT scan and DEXA scan', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adipose', 'lean', 'obese', 'overweight', 'healthy'], 'conditions': ['Healthy', 'Obesity']}, 'descriptionModule': {'briefSummary': 'This project was created to assess sex differences in adipose tissue gene expression in different locations in the body. The primary objectives are to understand:\n\n1. The mechanisms of differential body fat distribution in men and women\n2. How body fat distribution is affected by reproductive hormones\n3. The mechanisms linking fat distribution to health risks such as diabetes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'General Population', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian men and women 20-35 years of age\n* Lean (BMI less than 25)\n* Obese (BMI 30-35)\n\nExclusion Criteria:\n\n* Hormonal birth control\n* Pregnancy\n* Smokers\n* History of diabetes, kidney, liver or thyroid disease\n* History of cancer'}, 'identificationModule': {'nctId': 'NCT00677651', 'briefTitle': 'Sex Differences in Gene Expression in Human Adipose Tissue', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Diego'}, 'officialTitle': 'Sex Differences in Gene Expression in Human Adipose Tissue', 'orgStudyIdInfo': {'id': '070668'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Five caucasian women', 'interventionNames': ['Procedure: Adipose Biopsy', 'Procedure: Blood sample', 'Radiation: CT Scan', 'Radiation: DEXA']}, {'label': '2', 'description': 'Five caucasian men', 'interventionNames': ['Procedure: Adipose Biopsy', 'Procedure: Blood sample', 'Radiation: CT Scan', 'Radiation: DEXA']}], 'interventions': [{'name': 'Adipose Biopsy', 'type': 'PROCEDURE', 'description': 'Adipose tissue will be sampled from the abdomen and buttock', 'armGroupLabels': ['1', '2']}, {'name': 'Blood sample', 'type': 'PROCEDURE', 'description': 'Blood will be sampled from an IV line', 'armGroupLabels': ['1', '2']}, {'name': 'CT Scan', 'type': 'RADIATION', 'description': 'Single image at the level of the liver', 'armGroupLabels': ['1', '2']}, {'name': 'DEXA', 'type': 'RADIATION', 'description': 'Whole body scan', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91963-0063', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}], 'overallOfficials': [{'name': 'Jeffrey Chang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCSD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Diego', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Maryland', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'R. Jeffrey Chang, MD', 'oldOrganization': 'University of California, San Diego'}}}}