Identification of Novel Targets for Regulation of Adipose Tissue Mass

This study is currently recruiting participants.

Verified by University of Heidelberg, October 2008

Sponsors and Collaborators:	University of Heidelberg Swiss Federal Institute of Technology
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00773565

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

MedlinePlus related topics: Diabetes Obesity Weight Control

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Open Label, Single Group Assignment

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

number of adipocytes and preadipocytes under weight loss [ Time Frame: three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

metabolic function of adipocytes and preadipocytes under weight loss [ Time Frame: three years ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	October 2008
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Optifast Patients included take part at a weight reduction programm over one year.	Dietary Supplement: Optifast Formula diet for twelve weeks combined with physical activity and behavioral therapy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participants of the OPTIFAST52 programm
BMI > 30 kg/m2

Exclusion Criteria:

Rejection of informed consent by the participant

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00773565

Contacts

Contact: Gottfried Rudofsky, MD

0049622156 ext 38620

gottfried_rudofsky@med.uni-heidelberg.de

Locations

Germany
University Hospital Heidelberg	Recruiting
Heidelberg, Germany, 69115
Contact: Gottfried Rudofsky, MD 0049622156 ext 38620 gottfried_rudofsky@med.uni-heidelberg.de

Sponsors and Collaborators

University of Heidelberg

Swiss Federal Institute of Technology

Investigators

Study Chair:

Christian Wolfrum, PhD

ETH Zürich

More Information

Responsible Party:	University Hospital of Heidelberg ( Gottfried Rudofsky, MD )
Study ID Numbers:	EFSD-CRP-2008
Study First Received:	October 15, 2008
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00773565
Health Authority:	Germany: Ethics Commission

Keywords provided by University of Heidelberg:

patients with obesity (BMI > 30 kg/m2)

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 14, 2009