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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by McMaster University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Heart and Stroke Foundation of Canada
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00249314
First received: November 3, 2005
Last updated: April 18, 2007
Last verified: April 2007
  Purpose

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
Insulin Resistance
Type 2 Diabetes Mellitus
Cardiovascular Diseases

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Official Title: A Prospective, Cross-Sectional, Case-Control, Molecular Study of Health Assessment and Risk in Ethnic Groups

Resource links provided by NLM:


Further study details as provided by McMaster University:

Estimated Enrollment: 120
Study Start Date: November 2005
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00249314

Contacts
Contact: Suzana Damjanovic, MLT, CCRA 905-527-4322 ext 44710 suzana@cardio.on.ca

Locations
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
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00249314     History of Changes
Other Study ID Numbers: Mol-SHARE
Study First Received: November 3, 2005
Last Updated: April 18, 2007
Health Authority: Canada: Health Canada

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:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on July 31, 2014