Adipogenic Capacity as a Mediator of Weight Gain

Obesity Clinical Trial

Official title:

The Role of the Genetic Background Involved in Weight Regain Through Mechanisms Including Energy Expenditure, Physical Activity and Adipogenic Capacity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01015508
• Other study ID #: HumBio_Westerterp09
• Status: Active, not recruiting
• Phase: N/A
• First received: November 17, 2009
• Last updated: October 24, 2012
• Start date: February 2010
• Est. completion date: November 2012

Study information

• Verified date: October 2012
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

To demonstrate differences in response of subjects with a high, low or medium predisposition for weight regain after weight reduction in terms of: body composition; energy expenditure; physical activity; and adipogenic capacity.

Description:

The risk for weight regain after weight loss is a major problem for the current obesity treatments, and is largely genetically determined. It is believed that an elucidation of the genetic component in the prognosis of weight management could assist in the development of more effective and individually tailored treatments. However, current research on the genetic component of weight management, and in particular weight regain, is still limited and data available are sometimes inconsistent. The current research proposal aims to identify groups with a high, low or medium predisposition for weight regain, based on a genetic profile and to demonstrate differences in the response of these subjects to a weight maintenance period after weight reduction in terms of body composition, physical activity, adipogenic capacity and energy expenditure.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• BMI 28-35

• healthy, no medication

• no smoking

• stable weight (no weight loss/gain > 5kg in 3 months prior to study)

Exclusion Criteria:

• 28< BMI >35

• use of medication

• smoking

• weight loss/gain > 5kg in 3 months prior to study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Very Low Energy Diet (VLED)
a VLED (Modifast) for 2 months in order to reduce body weight
• Weight maintenance
10 months

Locations

Country	Name	City	State
Netherlands	Dept. of Human Biology (Maastricht University)	Maastricht	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Energy expenditure		0, 2 and 12 months	No
Secondary	Adipogenic capacity, Physical activity and body composition		0, 2 and 12 months	No