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Metabolic Effects of Birth Weight on Overweight and Obese Chinese Adults and Their Responses to Weight Loss (SAMS-2)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by National University Hospital, Singapore.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01080378
First received: February 28, 2010
Last updated: March 3, 2010
Last verified: March 2010

February 28, 2010
March 3, 2010
April 2010
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Complete list of historical versions of study NCT01080378 on ClinicalTrials.gov Archive Site
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Metabolic Effects of Birth Weight on Overweight and Obese Chinese Adults and Their Responses to Weight Loss
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.

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.

Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
  • Healthy
  • Overweight
  • Obesity
Procedure: Dietary and Exercise Intervention
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).
  • Higher Birth Weight
    3447g to 3879g
    Intervention: Procedure: Dietary and Exercise Intervention
  • Lower Birth Weight
    2624g to 2964g
    Intervention: Procedure: Dietary and Exercise Intervention
  • Normal Birth Weight
    2965g to 3446g
    Intervention: Procedure: Dietary and Exercise Intervention
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
180
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Inclusion Criteria:

  1. Ability to give informed consent
  2. Chinese males (aged 21-40)
  3. Body mass index between 23-30 kg/m2
  4. Total body fat content >24%
  5. Sedentary adults < 1 episode of exercise > =30 min/week
  6. Birth weight between 5-95% percentiles
  7. Fasting glucose < 7 mmol/L
  8. Normotensive, defined as BP < 140/90 mmHg and not on any antihypertensive agents

Exclusion Criteria:

  1. Recent changes in weight of >5% over the past 6 months
  2. Attempts to lose weight (weight not stable, exercises still changing and not in maintenance phase) over the past 6 months
  3. Significant changes in diet over the past 6 months
  4. Any use of weight reducing drugs in the past 6 months
  5. Previous abdominal surgery (and bariatric surgery)
  6. Any bleeding disorders which would preclude biopsies
  7. Any use of investigational drugs in the past 6 months
  8. Known allergy to insulin or local anaesthetics
  9. Known allergy to milk or milk products (eg. Ensure, liquid meal)
  10. Any serious illness requiring hospitalization or surgery in the past 6 months
  11. Treatment with medications for hypertension, diabetes mellitus or dyslipidemia, epilepsy, ischemic heart disease
  12. On anti-platelet agents, non-steroidal anti-inflammatory drugs (NSAIDs) or anticoagulants
  13. Use of any prescription medication that cannot be safely discontinued within 14 days prior to study entry
  14. Any use of corticosteroids in the past 6 months
  15. Any other medications that could alter insulin resistance
  16. History of surgery with metallic clips, staples or stents
  17. Presence of cardiac pacemaker or other foreign body in any part of the body including tattoos
  18. Mother no longer alive or unable to provide information on birth weight
  19. Born premature (ie. not full term baby < 37 weeks of gestation age)
Male
21 Years to 40 Years
Yes
Singapore
 
NCT01080378
DSRB C/09/604
No
Associate Professor Chong Yap Seng, National University of Singapore (NUHS)
National University Hospital, Singapore
National Medical Research Council (NMRC), Singapore
Principal Investigator: Yung Seng Lee National University Hospital, Singapore
National University Hospital, Singapore
March 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP