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

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. Identifier: NCT00249314
Recruitment Status : Unknown
Verified April 2007 by McMaster University.
Recruitment status was:  Recruiting
First Posted : November 7, 2005
Last Update Posted : April 19, 2007
Heart and Stroke Foundation of Canada
Information provided by:
McMaster University

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.

Condition or disease
Insulin Resistance Type 2 Diabetes Mellitus Cardiovascular Diseases

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.

Study Type : Observational
Enrollment : 120 participants
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: A Prospective, Cross-Sectional, Case-Control, Molecular Study of Health Assessment and Risk in Ethnic Groups
Study Start Date : November 2005
Estimated Study Completion Date : December 2007

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00249314

Contact: Suzana Damjanovic, MLT, CCRA 905-527-4322 ext 44710

Canada, Ontario
Hamilton Health Sciences - Cardiovascular Obesity Research and Management Center Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Principal Investigator: Arya M Sharma, MD, FRCPC         
Sponsors and Collaborators
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 Identifier: NCT00249314     History of Changes
Other Study ID Numbers: Mol-SHARE
First Posted: November 7, 2005    Key Record Dates
Last Update Posted: April 19, 2007
Last Verified: April 2007

Keywords provided by McMaster University:
South Asians
European Caucasians
ethnic differences
body composition
body fat distribution
adipose tissue
visceral fat
myocellular lipids
skeletal muscle

Additional relevant MeSH terms:
Diabetes Mellitus
Cardiovascular Diseases
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases