(Mol-SHARE) Molecular Study of Health Assessment and Risk in Ethnic Groups
Recruitment status was Recruiting
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| First Received Date ICMJE | November 3, 2005 | ||||||||||||
| Last Updated Date | April 18, 2007 | ||||||||||||
| Start Date ICMJE | November 2005 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Change History | Complete list of historical versions of study NCT00249314 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | (Mol-SHARE) Molecular Study of Health Assessment and Risk in Ethnic Groups | ||||||||||||
| Official Title ICMJE | A Prospective, Cross-Sectional, Case-Control, Molecular Study of Health Assessment and Risk in Ethnic Groups | ||||||||||||
| Brief Summary | The purpose of this study is to directly compare the body composition, body fat distribution, and morphological and functional features of adipose tissue and skeletal muscle between South Asians and European Caucasians. |
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| Detailed Description | Excess body fat, the hallmark of obesity is a major risk factor for the development of insulin resistance (decreased insulin sensitivity), type 2 diabetes, and cardiovascular disease. Previous studies have shown that South Asians (people who originate from the Indian subcontinent) appear particularly prone to develop diabetes and heart disease compared to white Caucasians of European origin. In Canada, in the Study of Health Assessment and Risk in Ethnic groups (SHARE), it was observed that in a random selection of South Asian and European individuals, South Asians had twice as much type 2 diabetes and cardiovascular disease and were significantly more insulin resistant than Europeans despite a similar body mass index (BMI) and waist circumference. It is possible that the increased propensity of South Asians to develop insulin resistance, type 2 diabetes, and cardiovascular disease is related to greater total body fat and/or increased visceral fat in addition to the possible biological differences in adipose tissue and skeletal muscle tissues. The primary objective of this study is therefore to determine differences among age, sex, and BMI-matched people of South Asian and European Caucasian descent in body composition (specifically total body fat, lean body mass) and fat distribution (where the fat is stored in the body). This study will therefore test the hypothesis that for a similar BMI, South Asians have more total body fat and less lean body mass than age and sex-matched European Caucasians. The secondary objectives of this study are to look at the differences in the two ethnic groups at a biological level, including: differences in visceral fat, adipose tissue morphology, imflammation and adipokine production, skeletal muscle fat content, fatty acid oxidation and mitochondrial activity. |
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| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Observational Model: Defined Population Primary Purpose: Screening Time Perspective: Cross-Sectional Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Not Provided | ||||||||||||
| Sampling Method | Not Provided | ||||||||||||
| Study Population | Not Provided | ||||||||||||
| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||
| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Enrollment ICMJE | 120 | ||||||||||||
| Estimated Completion Date | December 2007 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years to 50 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00249314 | ||||||||||||
| Other Study ID Numbers ICMJE | Mol-SHARE | ||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||
| Responsible Party | Not Provided | ||||||||||||
| Study Sponsor ICMJE | Hamilton Health Sciences Corporation | ||||||||||||
| Collaborators ICMJE | Heart and Stroke Foundation of Canada | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | McMaster University | ||||||||||||
| Verification Date | April 2007 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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