Insulin ResistanceNCT00249314
(Mol-SHARE) Molecular Study of Health Assessment and Risk in Ethnic Groups
An observational study of Insulin Resistance and Type 2 Diabetes Mellitus, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Type 2 Diabetes Mellitus, Cardiovascular Diseases
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2005to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.)
Show all 26Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences - Cardiovascular Obesity Research and Management Center
Hamilton, Ontario, L8L 2X2
Arya M Sharma, MD, FRCPC
About this study
Official title: A Prospective, Cross-Sectional, Case-Control, Molecular Study of Health Assessment and Risk in Ethnic Groups
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.
- Keywords
- South Asians, European Caucasians, ethnic differences, body composition, body fat distribution, adipose tissue, visceral fat, myocellular lipids, skeletal muscle
- Medical subject headings
- Insulin Resistance, Diabetes Mellitus, Type 2, Cardiovascular Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startNov 2005
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Investigators
- Arya M Sharma, MD, FRCPC, Principal investigator, McMaster UniversitySonia Anand, MD, FRCPC, Principal investigator, McMaster UniversityMark Tarnopolsky, MD, FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249314
- Sponsor's protocol ID
- Mol-SHARE
- Status last verified
- Apr 2007
- First submitted
- 3 Nov 2005
- Last updated
- 19 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Cross-Sectional, Case-Control, Molecular Study of Health Assessment and Risk in Ethnic Groups
- ClinicalTrials.gov ID
- NCT00249314
- Acronym / sponsor ID
- Mol-SHARE
- Keywords
- South Asians, European Caucasians, ethnic differences, body composition, body fat distribution, adipose tissue, visceral fat, myocellular lipids
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- Heart and Stroke Foundation of Canada
- Study start
- Nov 2005
- Study completion
- Dec 2007 (estimated)
- First posted
- 7 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Written informed consent
- Between 18-50 years of age
- Fits into one of the following BMI-Strata:
- Ability and willingness to complete dietary and activity diaries and questionnaires
Key exclusion criteria (26 listed)
- 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:
- Anticoagulant therapy (e.g. Coumadin)
- Orthopaedic contraindication to exercise test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Insulin Resistance and Type 2 Diabetes Mellitus, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suzana Damjanovic, MLT, CCRA (905-527-4322 ext. 44710, suzana@cardio.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2007.