Back to resultsIdentification of Novel Targets for Regulation of Adipose Tissue Mass
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Optifast
Sponsored by
About this trial
This is an interventional basic science trial for Obesity focused on measuring patients with obesity (BMI > 30 kg/m2)
Eligibility Criteria
Inclusion Criteria:
- Participants of the OPTIFAST52 program
- BMI > 30 kg/m2
Exclusion Criteria:
- Rejection of informed consent by the participant
Sites / Locations
- University Hospital Heidelberg
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Optifast
Arm Description
Patients included take part at a weight reduction program over one year.
Outcomes
Primary Outcome Measures
number of adipocytes and preadipocytes under weight loss
Secondary Outcome Measures
metabolic function of adipocytes and preadipocytes under weight loss
Full Information
NCT ID
NCT00773565
First Posted
October 15, 2008
Last Updated
August 22, 2012
Sponsor
Gottfried Rudofsky
Collaborators
Swiss Federal Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT00773565
Brief Title
Identification of Novel Targets for Regulation of Adipose Tissue Mass
Official Title
Identification of Novel Targets for Regulation of Adipose Tissue Mass
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gottfried Rudofsky
Collaborators
Swiss Federal Institute of Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
patients with obesity (BMI > 30 kg/m2)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Optifast
Arm Type
Other
Arm Description
Patients included take part at a weight reduction program over one year.
Intervention Type
Dietary Supplement
Intervention Name(s)
Optifast
Intervention Description
Formula diet for twelve weeks combined with physical activity and behavioral therapy
Primary Outcome Measure Information:
Title
number of adipocytes and preadipocytes under weight loss
Time Frame
three years
Secondary Outcome Measure Information:
Title
metabolic function of adipocytes and preadipocytes under weight loss
Time Frame
three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants of the OPTIFAST52 program
BMI > 30 kg/m2
Exclusion Criteria:
Rejection of informed consent by the participant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Wolfrum, PhD
Organizational Affiliation
ETH Zürich
Official's Role
Study Chair
Facility Information:
Facility Name
University Hospital Heidelberg
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Identification of Novel Targets for Regulation of Adipose Tissue Mass
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