NCT01080378

Brief 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. We also aim to determine the efficacy of a weight loss intervention on the above mentioned metabolic parameters in these individuals.

Trial Health

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Trial Health Score

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

Enrollment
180

participants targeted

Target at P75+ for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 4, 2010

Completed
28 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
Last Updated

March 4, 2010

Status Verified

March 1, 2010

First QC Date

February 28, 2010

Last Update Submit

March 3, 2010

Conditions

HealthyOverweightObesity

Study Arms (3)

Higher Birth Weight

OTHER

3447g to 3879g

Procedure: Dietary and Exercise Intervention

Lower Birth Weight

OTHER

2624g to 2964g

Procedure: Dietary and Exercise Intervention

Normal Birth Weight

OTHER

2965g to 3446g

Procedure: Dietary and Exercise Intervention

Interventions

Dietary and Exercise InterventionPROCEDURE

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 WeightLower Birth WeightNormal Birth Weight

Eligibility Criteria

Age21 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National University Hospital

Singapore, Singapore

Location

SGH Life Centre

Singapore, Singapore

Location

MeSH Terms

Conditions

OverweightObesity

Interventions

Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Yung Seng Lee

    National University Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 28, 2010

First Posted

March 4, 2010

Study Start

April 1, 2010

Last Updated

March 4, 2010

Record last verified: 2010-03

Locations

SG(2)