Identification of Novel Targets for Regulation of Adipose Tissue Mass

This study has been completed.
Sponsor:
Collaborator:
Swiss Federal Institute of Technology
Information provided by (Responsible Party):
Gottfried Rudofsky, University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00773565
First received: October 15, 2008
Last updated: August 22, 2012
Last verified: August 2012
  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: 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 Heidelberg University:

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 ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 ETH Zürich
  More Information

No publications provided

Responsible Party: Gottfried Rudofsky, Oberarzt, University of Heidelberg
ClinicalTrials.gov Identifier: NCT00773565     History of Changes
Other Study ID Numbers: EFSD-CRP-2008
Study First Received: October 15, 2008
Last Updated: August 22, 2012
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014