To Investigate the Influence of Ethnicity in Metabolic Disease in Healthy, Overweight and Obese Subjects (SAMS-1)

February 28, 2010 updated by: National University Hospital, Singapore

Developmental Pathways to Metabolic Diseases: Metabolic Physiology, Epigenetics and Body Composition in Healthy Overweight and Obese Subjects With a Fixed Range of Body Mass Index in Singapore - To Investigate the Influence of Ethnicity

The overall objective of this study is to investigate in depth the nature of metabolic physiology, body composition and epigenetic differences of the different phenotypes of overweight and obese individuals who are otherwise overtly healthy among the three major ethnic groups in Singapore.

Study Overview

Status

Unknown

Detailed Description

Over the past decade, investigators in Singapore have been actively studying the impact of ethnicity on metabolic traits, particularly those related to insulin resistance (detailed in the preliminary data of this proposal. We have observed that, for the same BMI, Asian Indians appear to have greater insulin resistance than Chinese. In line with the greater insulin resistance observed in Asian Indians, it has also been noted that Asian Indians exhibit greater central obesity (manifest as a larger waist circumference). In some ways, this resembles the phenotype that might be expected if the mismatch pathway described in this proposal, were involved in the pathogenesis of insulin resistance in this ethnic group. Interestingly, Asian Indians have also been noted to have lower birth weight than Chinese in our population. In contrast, although Malays are more insulin resistant than Chinese, this is largely due to greater adiposity and, after adjustment for body mass index, Malays are actually less insulin resistant than their Chinese and Asian Indian counterparts. They also have smaller waist circumferences. It is also recognized that pregnant Malay women tend to be generally more obese than their Chinese and Asian Indian counterparts, which may put their children at great risk of fetal hyperinsulinemia. As such, the potential exists that this latter pathway is more active in the pathogenesis of insulin resistance in this ethnic group.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore
        • Recruiting
        • National University Hospital
        • Contact:
        • Principal Investigator:
          • Melvin Leow
        • Sub-Investigator:
          • Eric Khoo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Singapore population

Description

Inclusion Criteria:

  1. Ability to give informed consent
  2. Chinese, Malay or Indian males (aged 21-40)
  3. Body mass index between 23-30 kg/m2 for the overweight or obese subjects and between 18.5 to 22.9 kg/m2 for the Chinese control group
  4. Sedentary adults < 1 episode of exercise > =30 min/week
  5. Birth weight between 3-97% percentiles
  6. Fasting glucose < 7 mmol/L
  7. Normotensive, defined as BP < 140/90 mmHg and not on any antihypertensive agents

Exclusion Criteria:

  1. Recent changes in weight of > 5% over the past 6 months
  2. Attempts to lose weight (weight not reaching equilibrium, exercises still changing and not in maintenance phase) over the past 6 months
  3. Significant changes in diet over the past 6 months
  4. Any use of weight reducing drugs in the past 6 months
  5. Previous abdominal surgery (and bariatric surgery)
  6. Any bleeding disorders which would preclude biopsies
  7. Any use of investigational drugs in the past 6 months
  8. Known allergy to insulin or local anesthetics
  9. Known allergy to milk or milk products (eg. Ensure)
  10. Any serious illness requiring hospitalization or surgery in the past 6 months
  11. Treatment with medications for hypertension, diabetes mellitus or dyslipidemia, epilepsy, ischemic heart disease
  12. On anti-platelet agents, non-steroidal anti-inflammatory drugs (NSAIDs) or anticoagulants
  13. Use of any prescription medication that cannot be safely discontinued within 14 days prior to study entry
  14. Any use of corticosteroids in the past 6 months
  15. Any other medications that could alter insulin resistance
  16. History of surgery with metallic clips, staples or stents
  17. Presence of cardiac pacemaker or other foreign body in any part of the body
  18. Mother no longer alive or unable to provide information on birth weight
  19. Born premature (ie. not full term baby < 37 weeks of gestation age)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
No treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: E Shyong Tai, National University Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Study Registration Dates

First Submitted

October 1, 2009

First Submitted That Met QC Criteria

October 1, 2009

First Posted (ESTIMATE)

October 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 28, 2010

Last Verified

February 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSRB C/09/022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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