Identification of Novel Targets for Regulation of Adipose Tissue Mass
Identification of Novel Targets for Regulation of Adipose Tissue Mass
Sponsors
Source
Heidelberg University
Oversight Info
Has Dmc
No
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.
Overall Status
Completed
Start Date
2008-10-01
Completion Date
2011-08-01
Primary Completion Date
2011-08-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
number of adipocytes and preadipocytes under weight loss |
three years |
Secondary Outcome
Measure |
Time Frame |
|
metabolic function of adipocytes and preadipocytes under weight loss |
three years |
Enrollment
62
Condition
Intervention
Intervention Type
Dietary Supplement
Intervention Name
Description
Formula diet for twelve weeks combined with physical activity and behavioral therapy
Arm Group Label
Optifast
Eligibility
Criteria
Inclusion Criteria:
- Participants of the OPTIFAST52 program
- BMI > 30 kg/m2
Exclusion Criteria:
- Rejection of informed consent by the participant
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Christian Wolfrum, PhD |
Study Chair |
University of Zurich |
Location
Facility |
|
University Hospital Heidelberg Heidelberg 69115 Germany |
Location Countries
Country
Germany
Verification Date
2012-08-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor-Investigator
Investigator Affiliation
Heidelberg University
Investigator Full Name
Gottfried Rudofsky
Investigator Title
Oberarzt
Keyword
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Arm Group
Arm Group Label
Optifast
Arm Group Type
Other
Description
Patients included take part at a weight reduction program over one year.
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)
Study First Submitted
October 15, 2008
Study First Submitted Qc
October 15, 2008
Study First Posted
October 16, 2008
Last Update Submitted
August 22, 2012
Last Update Submitted Qc
August 22, 2012
Last Update Posted
August 23, 2012
ClinicalTrials.gov processed this data on December 06, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.