HealthySAMS-2NCT01080378
Metabolic Effects of Birth Weight on Overweight and Obese Chinese Adults and Their Responses to Weight Loss
A study testing Dietary and Exercise Intervention in people with Healthy and Overweight, run by National University Hospital, Singapore at 2 sites in Singapore.
Trial summary
The overall objective of this study is to investigate in depth the impact of birth weight on the nature of metabolic physiology, body composition and epigenetic differences of the different phenotypes of overweight and obese individuals who are otherwise overtly healthy. 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
- What is being tested?
- Dietary and Exercise Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 2 sitesSingapore
- Study dates
- Apr 2010to not given
- Phase
- Interventional
- 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
Who may be able to join
- Ability to give informed consent
- Chinese males (aged 21-40)
- Body mass index between 23-30 kg/m2
- Total body fat content >24%
- Sedentary adults < 1 episode of exercise > =30 min/week
- Birth weight between 5-95% 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 stable, 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 anaesthetics
- Known allergy to milk or milk products (eg. Ensure, liquid meal)
- 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 including tattoos
- 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
2 sites in 1 country.
Singapore2 sites
National University Hospital
Singapore
Gladys Woon, obgwsmg@nus.edu.sg
Eric Khoo
SGH Life Centre
Singapore
Kwang Wei Tham
About this study
Official title: Developmental Pathways to Metabolic Diseases: To Investigate the Metabolic Effects of Birth Weight on Overweight and Obese Chinese Adults and Their Responses to Weight Loss Over 16 Weeks
The overall objective of this study is to investigate in depth the impact of birth weight on the nature of metabolic physiology, body composition and epigenetic differences of the different phenotypes of overweight and obese individuals who are otherwise overtly healthy. We also aim to determine the efficacy of a weight loss intervention on the above mentioned metabolic parameters in these individuals.
Read the detailed description
There is an exponential rise in the prevalence of type 2 diabetes and obesity in Singapore coincident with rapid nutritional and socioeconomic transition. Differing birth weights, even in the normal ranges, predisposes individuals to the risk of type 2 diabetes and obesity. We aim to examine the causal pathways, developmental contribution and effects of a weight loss intervention to this differential by evaluating the hypothesis that genomic, birth weight, developmental, lifestyle and environmental factors contribute to the variation in phenotype observed in adults with obesity and metabolic syndrome.
Although there are many large studies that examined the effect of birth weight on the expression of obesity and the metabolic syndrome phenotype, most of these studies usually lack in-depth physiological and epigenetic/genomic studies due to their large sample sizes. We therefore aim to explore such detailed aspects of physiological and epigenetic/genomic profiles on smaller but statistically powered samples, focusing on evaluating body composition, nutritional and metabolic phenotype in relationship to epigenetic/genetic markers and developmental history. In addition, we examine the effects of a weight loss intervention on these parameters. This will assist in weighing the importance of developmental and genetic pathways in contributing to individual risk and the response and efficacy to an intervention.
- Conditions
- Healthy, Overweight, Obesity
- Being tested
- Dietary and Exercise Intervention
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary and Exercise InterventionProcedure or surgery
Participants will be enrolled into a 16 weeks weight loss programme that consists of (a) dietary interventions and (b) structured exercise sessions and (c) physical activity to achieve 7 - 10% decrease (more than 8 kg) in initial body weight in 16 weeks. They will be subjected to a caloric deficit of 40% of the subject's energy expenditure or 1000kcal, which ever it is higher. (allowance given for dietary control and physical activity).
| Study group | Role | What they receive |
|---|---|---|
| Higher Birth Weight | Other | 3447g to 3879g Receives: Procedure: Dietary and Exercise Intervention |
| Lower Birth Weight | Other | 2624g to 2964g Receives: Procedure: Dietary and Exercise Intervention |
| Normal Birth Weight | Other | 2965g to 3446g Receives: Procedure: Dietary and Exercise Intervention |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2010 (estimated)
- Study startApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 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
- Yung Seng Lee, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01080378
- Sponsor's protocol ID
- DSRB C/09/604
- Acronym
- SAMS-2
- Status last verified
- Mar 2010
- First submitted
- 28 Feb 2010
- Last updated
- 4 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developmental Pathways to Metabolic Diseases: To Investigate the Metabolic Effects of Birth Weight on Overweight and Obese Chinese Adults and Their Responses to Weight Loss Over 16 Weeks
- ClinicalTrials.gov ID
- NCT01080378
- Acronym / sponsor ID
- SAMS-2 / DSRB C/09/604
- Conditions
- Healthy, Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National Medical Research Council (NMRC), Singapore
- Study start
- Apr 2010
- First posted
- 4 Mar 2010 (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 impact of birth weight on the nature of metabolic physiology, body composition and epigenetic differences of the different phenotypes of overweight and obese individuals who are otherwise overtly healthy. We also aim to determine the efficacy of a weight loss intervention on the above mentioned metabolic parameters in these individuals.
Detailed description
There is an exponential rise in the prevalence of type 2 diabetes and obesity in Singapore coincident with rapid nutritional and socioeconomic transition. Differing birth weights, even in the normal ranges, predisposes individuals to the risk of type 2 diabetes and obesity. We aim to examine the causal pathways, developmental contribution and effects of a weight loss intervention to this differential by evaluating the hypothesis that genomic, birth weight, developmental, lifestyle and environmental factors contribute to the variation in phenotype observed in adults with obesity and metabolic syndrome.
Although there are many large studies that examined the effect of birth weight on the expression of obesity and the metabolic syndrome phenotype, most of these studies usually lack in-depth physiological and epigenetic/genomic studies due to their large sample sizes. We therefore aim to explore such detailed aspects of physiological and epigenetic/genomic profiles on smaller but statistically powered samples, focusing on evaluating body composition, nutritional and metabolic phenotype in relationship to epigenetic/genetic markers and developmental history. In addition, we examine the effects of a weight loss intervention on these parameters. This will assist in weighing the importance of developmental and genetic pathways in contributing to individual risk and the response and efficacy to an intervention.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Higher Birth Weight | Other | Procedure: Dietary and Exercise Intervention3447g to 3879g |
| Lower Birth Weight | Other | Procedure: Dietary and Exercise Intervention2624g to 2964g |
| Normal Birth Weight | Other | Procedure: Dietary and Exercise Intervention2965g to 3446g |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Ability to give informed consent
- Chinese males (aged 21-40)
- Body mass index between 23-30 kg/m2
- Total body fat content >24%
- Sedentary adults < 1 episode of exercise > =30 min/week
Key exclusion criteria (19 listed)
- Recent changes in weight of >5% over the past 6 months
- Attempts to lose weight (weight not stable, 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dietary and Exercise InterventionParticipants will be enrolled into a 16 weeks weight loss programme that consists of (a) dietary interventions and (b) structured exercise sessions and (c) physical activity to achieve 7 - 10% decrease (more than 8 kg) in initial body weight in 16 weeks. They will be subjected to a caloric deficit of 40% of the subject's energy expenditure or 1000kcal, which ever it is higher. (allowance given for dietary control and physical activity). | Procedure or surgery | Higher Birth Weight, Lower Birth Weight, Normal Birth Weight |
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 4 Mar 2010.
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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.
Yung Seng Lee principal investigator
National University Hospital, Singapore
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary and Exercise Intervention in people with Healthy and Overweight, run by National University Hospital, Singapore at 2 sites 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 8 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 4 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 2 sites 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?
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 4 Mar 2010.