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Identification of Novel Targets for Regulation of Adipose Tissue Mass

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00773565
First Posted: October 16, 2008
Last Update Posted: August 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Swiss Federal Institute of Technology
Information provided by (Responsible Party):
Gottfried Rudofsky, University of Heidelberg
  Purpose
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.

Condition Intervention
Obesity Dietary Supplement: Optifast

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Identification of Novel Targets for Regulation of Adipose Tissue Mass

Resource links provided by NLM:


Further study details as provided by Gottfried Rudofsky, University of Heidelberg:

Primary Outcome Measures:
  • number of adipocytes and preadipocytes under weight loss [ Time Frame: three years ]

Secondary Outcome Measures:
  • metabolic function of adipocytes and preadipocytes under weight loss [ Time Frame: three years ]

Enrollment: 62
Study Start Date: October 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Rejection of informed consent by the participant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00773565


Locations
Germany
University Hospital Heidelberg
Heidelberg, Germany, 69115
Sponsors and Collaborators
Gottfried Rudofsky
Swiss Federal Institute of Technology
Investigators
Study Chair: Christian Wolfrum, PhD University of Zurich
  More Information

Responsible Party: Gottfried Rudofsky, Oberarzt, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00773565     History of Changes
Other Study ID Numbers: EFSD-CRP-2008
First Submitted: October 15, 2008
First Posted: October 16, 2008
Last Update Posted: August 23, 2012
Last Verified: August 2012

Keywords provided by Gottfried Rudofsky, University of Heidelberg:
patients with obesity (BMI > 30 kg/m2)