Status:
UNKNOWN
(Mol-SHARE) Molecular Study of Health Assessment and Risk in Ethnic Groups
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Heart and Stroke Foundation of Canada
Conditions:
Insulin Resistance
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18-50 years
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 E...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
OBSERVATIONAL
End Date :
December 1 2007
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00249314
Start Date
November 1 2005
End Date
December 1 2007
Last Update
April 19 2007
Active Locations (1)
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1
Hamilton Health Sciences - Cardiovascular Obesity Research and Management Center
Hamilton, Ontario, Canada, L8L 2X2