Recruiting

Observational Study

Sponsor:

Hamilton Health Sciences Corporation

Code:

NCT00249314

Conditions

Insulin Resistance

Type 2 Diabetes Mellitus

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Insulin Resistance

Type 2 Diabetes Mellitus

Cardiovascular Diseases

Study ID

NCT00249314

Start date

Nov, 2005

Status verified date

Apr, 2007

Completion date

Dec, 2007

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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

Study Design

Enrollment

120 participants

Interventions and Outcome Measures

Central Contacts and Locations

Central contacts

Suzana Damjanovic, MLT, CCRA

905-527-4322suzana@cardio.on.ca

Locations

Hamilton Health Sciences - Cardiovascular Obesity Research and Management Center

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Principal Investigator:

Arya M Sharma, MD, FRCPC

More Information

Sponsor

Hamilton Health Sciences Corporation

Last update posted

Apr 19, 2007

Last verified

Apr, 2007

Keywords

  • South Asians
  • European Caucasians
  • ethnic differences
  • body composition
  • body fat distribution
  • adipose tissue
  • visceral fat
  • myocellular lipids
  • skeletal muscle

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hamilton Health Sciences Corporation on 2007-04-19.