- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00988819
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
Conditions
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
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Singapore, Singapore
- Recruiting
- National University Hospital
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Contact:
- Gladys Woon
- Email: gladys_woon@nuhs.edu.sg
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Principal Investigator:
- Melvin Leow
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Sub-Investigator:
- Eric Khoo
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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:
- 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 Criteria:
- 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)
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 |
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No treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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.
General Publications
- 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.
- 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.
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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