HealthySAMS-1NCT00988819
To Investigate the Influence of Ethnicity in Metabolic Disease in Healthy, Overweight and Obese Subjects
An observational study of Healthy and Overweight, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy, Overweight, Obesity
- How many people
- 200 participants
- Where
- 1 siteSingapore
- Study dates
- Jul 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Singapore population
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore
Gladys Woon, gladys_woon@nuhs.edu.sg
Melvin Leow
About this study
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
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.
Read the 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.
- Conditions
- Healthy, Overweight, Obesity
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
- Study startJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Investigators
- E Shyong Tai, Principal investigator, National University Hospital, SingaporeYung Seng Lee, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988819
- Sponsor's protocol ID
- DSRB C/09/022
- Acronym
- SAMS-1
- Status last verified
- Feb 2010
- First submitted
- 1 Oct 2009
- Last updated
- 2 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 30137523Lee 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.
PubMed 23553164
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00988819
- Acronym / sponsor ID
- SAMS-1 / DSRB C/09/022
- Conditions
- Healthy, Overweight, Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- Jul 2009
- First posted
- 2 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | – |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Singapore population
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2010.
- Derived from this study: PubMed 30137523Tan 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.
- Derived from this study: PubMed 23553164Lee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E Shyong Tai principal investigator
National University Hospital, Singapore
Yung Seng Lee principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Overweight, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00988819, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2010.