Trial record 4 of 582 for:    obesity, overweight, and body composition

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by National University Hospital, Singapore.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00988819
First received: October 1, 2009
Last updated: February 28, 2010
Last verified: February 2010
  Purpose

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.


Condition
Healthy
Overweight
Obesity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Biospecimen Retention:   Samples With DNA

plasma, serum, packed cells, blood clot, urine, buccal cells, muscle tissue


Estimated Enrollment: 200
Study Start Date: July 2009
Groups/Cohorts
No treatment

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.

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Singapore population

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00988819

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore
Contact: Gladys Woon       gladys_woon@nuhs.edu.sg   
Principal Investigator: Melvin Leow         
Principal Investigator: Chin Meng Khoo         
Sub-Investigator: Eric Khoo         
Sponsors and Collaborators
National University Hospital, Singapore
National Medical Research Council (NMRC), Singapore
Investigators
Principal Investigator: E Shyong Tai National University Hospital, Singapore
Principal Investigator: Yung Seng Lee National University Hospital, Singapore
  More Information

No publications provided by National University Hospital, Singapore

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Associate Professor Chong Yap Seng, National University of Singapore (NUHS)
ClinicalTrials.gov Identifier: NCT00988819     History of Changes
Other Study ID Numbers: DSRB C/09/022
Study First Received: October 1, 2009
Last Updated: February 28, 2010
Health Authority: Singapore: Domain Specific Review Boards

Additional relevant MeSH terms:
Metabolic Diseases
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 16, 2014