Status:

UNKNOWN

To Investigate the Influence of Ethnicity in Metabolic Disease in Healthy, Overweight and Obese Subjects

Lead Sponsor:

National University Hospital, Singapore

Collaborating Sponsors:

National Medical Research Council (NMRC), Singapore

Conditions:

Healthy

Overweight

Eligibility:

MALE

21-40 years

Brief Summary

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 indiv...

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 ...

Eligibility Criteria

Inclusion

  • Ability to give informed consent
  • Chinese, Malay or Indian males (aged 21-40)
  • 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
  • Sedentary adults \< 1 episode of exercise \> =30 min/week
  • Birth weight between 3-97% percentiles
  • Fasting glucose \< 7 mmol/L
  • Normotensive, defined as BP \< 140/90 mmHg and not on any antihypertensive agents

Exclusion

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

Key Trial Info

Start Date :

July 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT00988819

Start Date

July 1 2009

Last Update

March 2 2010

Active Locations (1)

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1

National University Hospital

Singapore, Singapore

To Investigate the Influence of Ethnicity in Metabolic Disease in Healthy, Overweight and Obese Subjects | DecenTrialz