CClinicalTrials.gg
Status unknownNCT00249314Updated Apr 19, 2007

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

An observational study in Insulin Resistance, Type 2 Diabetes Mellitus and Cardiovascular Diseases, sponsored by Hamilton Health Sciences Corporation. Status unknown at 1 site in Canada. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2007-04-19.

Sponsored by Hamilton Health Sciences Corporation · Observational

The sponsor has not verified this record recently (last verified Apr 2007), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Defined population
Time perspective
Other
Enrollment
120
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Insulin Resistance
  • Type 2 Diabetes Mellitus
  • Cardiovascular Diseases

Keywords

  • South Asians
  • European Caucasians
  • ethnic differences
  • body composition
  • body fat distribution
  • adipose tissue
  • visceral fat
  • myocellular lipids
  • skeletal muscle
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 120 is below the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

Hamilton Health Sciences Corporation is the lead sponsor of 237 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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

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
05

Study design

Observational model
Defined population
Time perspective
Other
Enrollment
120 participants
06

Study locations

1 of 1 sites recruiting
  • Hamilton Health Sciences - Cardiovascular Obesity Research and Management Center
    Hamilton, Ontario L8L 2X2, Canada
    • Arya M Sharma, MD, FRCPC · Principal investigator
    Recruiting
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00249314
Lead sponsor
Hamilton Health Sciences Corporation
Collaborators
Heart and Stroke Foundation of Canada
First posted
Nov 7, 2005
Start date
Nov 2005
Completion
Dec 2007 (estimated)
Last update
Apr 19, 2007

Study contacts

Suzana Damjanovic, MLT, CCRA
Contact
suzana@cardio.on.ca
905-527-4322 ext. 44710
Arya M Sharma, MD, FRCPC
principal investigator · McMaster University
Sonia Anand, MD, FRCPC
principal investigator · McMaster University
Mark Tarnopolsky, MD, FRCPC
principal investigator · McMaster University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion