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(Mol-SHARE) Molecular Study of Health Assessment and Risk in Ethnic Groups

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2007 by McMaster University.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: November 7, 2005
Last Update Posted: April 19, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Heart and Stroke Foundation of Canada
Information provided by:
McMaster University
November 3, 2005
November 7, 2005
April 19, 2007
November 2005
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Complete list of historical versions of study NCT00249314 on ClinicalTrials.gov Archive Site
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(Mol-SHARE) Molecular Study of Health Assessment and Risk in Ethnic Groups
A Prospective, Cross-Sectional, Case-Control, Molecular Study of Health Assessment and Risk in Ethnic Groups
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.
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.
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
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  • Insulin Resistance
  • Type 2 Diabetes Mellitus
  • Cardiovascular Diseases
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
December 2007
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Inclusion Criteria:

  • Written informed consent
  • Between 18-50 years of age
  • Fits into one of the following BMI-Strata:

    • Stratum 1: BMI 18.5 – 25 kg/m2
    • Stratum 2: BMI 25.1 –29.9 kg/m2
    • Stratum 3: BMI 30 -45 kg/m2
  • Ability and willingness to complete dietary and activity diaries and questionnaires

Exclusion Criteria:

  • Concurrent antidiabetic, antithypertensive, antiobesity or lipid-lowering medication
  • Use of systemic glucocorticosteroids (topical and inhaled corticosteroids are acceptable)
  • If the participant has any one or more of the following medical disorders:

    • Known Diabetes
    • Known renal impairment
    • Known uncontrolled endocrine disorder (e.g. hyperthyroidism, Cushing’s syndrome, acromegaly, etc.)
    • Recent (less than three months) major surgery or hopitalization for severe illness
    • History of active malignancy, chronic inflammatory disorder, or chronic infections which would interfere with the protocol completion
    • Any other medical, social or geographic condition, which in the opinion of the investigator would not allow safe or reliable completion of the protocol
  • Anticoagulant therapy (e.g. Coumadin)
  • Orthopaedic contraindication to exercise test
  • Significant fluctuations in weight over past 3 months (e.g. >10%)
  • Extreme weight loss diets (e.g. Atkins, Bernstein)
  • History of drug or alcohol dependency within six months prior to signing the informed consent form
  • If the participant has any contraindications to MRI:

    • If the participant is clautrophobic or suffers from fear of closed spaces
    • If participant has had significant contact with metal (e.g. welding)
    • If participant has foreign body in their eye as confirmed by X-ray of the orbits
    • Body Mass Index > 45 kg/m2
    • Participant has had hip or joint replacement surgery 6-8 weeks prior to start of study
    • If participant has:

      • Cardiac pacemaker
      • Artificial cardiac valve
      • Aneurysm clip
      • Neurostimulator
      • Other implanted devices or metal objects in their body
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Hamilton Health Sciences Corporation
Heart and Stroke Foundation of Canada
Principal Investigator: Arya M Sharma, MD, FRCPC McMaster University
Principal Investigator: Sonia Anand, MD, FRCPC McMaster University
Principal Investigator: Mark Tarnopolsky, MD, FRCPC McMaster University
McMaster University
April 2007