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Identification of Novel Targets for Regulation of Adipose Tissue Mass

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ClinicalTrials.gov Identifier: NCT00773565
Recruitment Status : Completed
First Posted : October 16, 2008
Last Update Posted : August 23, 2012
Sponsor:
Collaborator:
Swiss Federal Institute of Technology
Information provided by (Responsible Party):
Gottfried Rudofsky, Heidelberg University

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Dietary Supplement: Optifast Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
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
Study Start Date : October 2008
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control
U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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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

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

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

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