Identification of Novel Targets for Regulation of Adipose Tissue Mass

August 22, 2012 updated by: Gottfried Rudofsky
The aim of this study is to understand the metabolic changes occurring in fat tissue both during controlled weight loss that lead to the improvement of type 2 diabetes and other obesity associated metabolic disorders. The novelty of the study is the analysis of preadipocytes, a poorly characterized subfraction of the adipose tissue, which provides adipocyte precursors and thereby strongly influences adipose tissue mass changes. Knowledge of pathways involved in controlling adipose tissue composition will help to design novel intervention strategies for the treatment of obesity associated metabolic disorders such as type 2 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Heidelberg, Germany, 69115
        • University Hospital Heidelberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants of the OPTIFAST52 program
  • BMI > 30 kg/m2

Exclusion Criteria:

  • Rejection of informed consent by the participant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Optifast
Patients included take part at a weight reduction program over one year.
Dietary supplement: Optifast
Formula diet for twelve weeks combined with physical activity and behavioral therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of adipocytes and preadipocytes under weight loss
Time Frame: three years
three years

Secondary Outcome Measures

Outcome Measure
Time Frame
metabolic function of adipocytes and preadipocytes under weight loss
Time Frame: three years
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gottfried Rudofsky

Collaborators

Swiss Federal Institute of Technology

Investigators

  • Study Chair: Christian Wolfrum, PhD, ETH Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

October 15, 2008

First Submitted That Met QC Criteria

October 15, 2008

First Posted (Estimate)

October 16, 2008

Study Record Updates

Last Update Posted (Estimate)

August 23, 2012

Last Update Submitted That Met QC Criteria

August 22, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFSD-CRP-2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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