Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT00438061
Status:
COMPLETED
Last Update Posted:
2007-02-26
First Post:
2007-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Abdominal Obesity on Lipoprotein Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], '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': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1995-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-02', 'completionDateStruct': {'date': '1998-12'}, 'lastUpdateSubmitDate': '2007-02-23', 'studyFirstSubmitDate': '2007-02-20', 'studyFirstSubmitQcDate': '2007-02-20', 'lastUpdatePostDateStruct': {'date': '2007-02-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary: Fractional catabolic and production rates of LDL-apoB and HDL-apoA-I (before and after 16 week treatments)'}], 'secondaryOutcomes': [{'measure': 'Secondary: Cholesterol; Triglyceride; LDL-cholesterol; Adipocytokines; Genetic polymorphism'}]}, 'conditionsModule': {'keywords': ['Lipoprotein metabolism', 'Cardiovascular disease', 'Obesity'], 'conditions': ['Obesity', 'Dyslipidemia', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'Abdominal obesity is strongly associated with dyslipidemia, which may account for the associated increased risk of atherosclerosis and coronary disease. Weight reduction is suggested to be a preferred and effective first-line strategy to correct lipid abnormalities, particularly in overweight/obese subjects. This improvement may be related to the effect of reduction in abdominal fat mass on apoB and apoA-I metabolism, but this remains to be fully demonstrated.\n\nHypothesis: Reduction in abdominal fat mass by weight loss decreases apoB concentration and raises HDL-cholesterol chiefly by increasing LDL-apoB fractional catabolic rate (FCR), as well as decreasing HDL apoA-I, respectively.', 'detailedDescription': 'We examined the mechanism of the effect of weight loss through dieting on LDL and HDL metabolism in abdominally obese men. LDL apoB-100 and HDL apoA-I kinetics were studied using a primed-constant infusion of 1-\\[13C\\]-leucine in a controlled, dietary intervention trial of 16 weeks duration in middle-aged, obese men with the metabolic syndrome. Isotopic enrichment in apoB and apoA-I was measured by gas chromatography-mass spectrometry and fractional turnover rates estimated using multi-compartmental modelling.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obesity was defined as a body mass index (BMI) \\>28kg/m2 and visceral visceral obesity (waist to hip ratio\\> 1.0 or waist circumference \\>100 cm)\n\nExclusion Criteria:\n\n* Diabetes mellitus,\n* Proteinuria,\n* Hypothyroidism,\n* Abnormal liver enzymes,\n* Major systemic illness,\n* A history of alcohol abuse,\n* A family history of hyperlipidemia or premature coronary artery disease or were taking medication known to affect lipid metabolism.'}, 'identificationModule': {'nctId': 'NCT00438061', 'briefTitle': 'Effect of Abdominal Obesity on Lipoprotein Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'The University of Western Australia'}, 'officialTitle': 'Effect of Weight Loss on Lipoprotein Metabolism in Abdominal Obesity', 'orgStudyIdInfo': {'id': 'EC-256'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Weight loss by dietary restriction', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '6000', 'city': 'Perth', 'state': 'Western Australia', 'country': 'Australia', 'facility': 'Royal Perth Hospital', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}], 'overallOfficials': [{'name': 'Dick C Chan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Western Australia'}, {'name': 'Gerald F Watts, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The University of Western Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Western Australia', 'class': 'OTHER'}}}}