NCT00988819

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 individuals who are otherwise overtly healthy among the three major ethnic groups in Singapore.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2009

Completed
Last Updated

March 2, 2010

Status Verified

February 1, 2010

First QC Date

October 1, 2009

Last Update Submit

February 28, 2010

Conditions

HealthyOverweightObesity

Study Arms (1)

No treatment

Eligibility Criteria

Age21 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Singapore population

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National University Hospital

Singapore, Singapore

RECRUITING

Related Publications (2)

  • Tan ALM, Langley SR, Tan CF, Chai JF, Khoo CM, Leow MK, Khoo EYH, Moreno-Moral A, Pravenec M, Rotival M, Sadananthan SA, Velan SS, Venkataraman K, Chong YS, Lee YS, Sim X, Stunkel W, Liu MH, Tai ES, Petretto E. Ethnicity-Specific Skeletal Muscle Transcriptional Signatures and Their Relevance to Insulin Resistance in Singapore. J Clin Endocrinol Metab. 2019 Feb 1;104(2):465-486. doi: 10.1210/jc.2018-00309.

    PMID: 30137523DERIVED

  • Lee Y, Chong MF, Liu JC, Libedinsky C, Gooley JJ, Chen S, Wu T, Tan V, Zhou M, Meaney MJ, Lee YS, Chee MW. Dietary disinhibition modulates neural valuation of food in the fed and fasted states. Am J Clin Nutr. 2013 May;97(5):919-25. doi: 10.3945/ajcn.112.053801. Epub 2013 Apr 3.

    PMID: 23553164DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • E Shyong Tai

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

  • Yung Seng Lee

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2009

First Posted

October 2, 2009

Study Start

July 1, 2009

Last Updated

March 2, 2010

Record last verified: 2010-02

Locations

SG(1)