Role of Adipose Tissue in Pathogenesis of Insulin Resistance
Primary Purpose
Obesity, Insulin Resistance
Status
Completed
Phase
Not Applicable
Locations
Czech Republic
Study Type
Interventional
Intervention
Hypocaloric diet
Sponsored by
About this trial
This is an interventional prevention trial for Obesity focused on measuring Obesity, Insulin resistance, Hypocaloric diet, Adipose tissue, adipocytokine
Eligibility Criteria
Inclusion Criteria:
- Obesity
Exclusion Criteria:
- Diabetes
- Coronary heart disease
- Eating disorders
- Medication of beta blockers
- Medication of antiobesity drugs
Sites / Locations
- Third Faculty of Medicine, Charles University in Prague
Outcomes
Primary Outcome Measures
Body weight
Body fat
Secondary Outcome Measures
Insulin resistance
Adipocytokine plasma levels
Adipocytokine adipose tissue expression
Full Information
NCT ID
NCT00439491
First Posted
February 21, 2007
Last Updated
February 21, 2007
Sponsor
Charles University, Czech Republic
1. Study Identification
Unique Protocol Identification Number
NCT00439491
Brief Title
Role of Adipose Tissue in Pathogenesis of Insulin Resistance
Official Title
Role of Adipose Tissue in Pathogenesis of Insulin Resistance
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Charles University, Czech Republic
4. Oversight
5. Study Description
Brief Summary
The aim of the study was to investigate the relationship between insulin resistance and body composition in relation to secterion and expression of adipocytokines. Obese subjects undergo 6 months hypocaloric diet and, before, during and at the end of the diet, plasma samples and subcutaneous adipose tissue samples are obtained for subsequent analysis. In addition, body composition and insulin resistance are measured before and during the diet.
Detailed Description
The aim of the study was to investigate the relationship between insulin resistance and body composition in relation to secterion and expression of adipocytokines. Obese subjects undergo 6 months hypocaloric diet without any medication and, before, during and at the end of the diet, plasma samples and subcutaneous adipose tissue samples are obtained for subsequent analysis. Adipose tissue samples are obtained using needle biopsy. In addition, before and during the diet,body composition is measured using multifrequency bioimpedance and insulin resistance is evaluated using either hyperinsulinemic clamp or glucose/insulin - derived indices.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Insulin Resistance
Keywords
Obesity, Insulin resistance, Hypocaloric diet, Adipose tissue, adipocytokine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Hypocaloric diet
Primary Outcome Measure Information:
Title
Body weight
Title
Body fat
Secondary Outcome Measure Information:
Title
Insulin resistance
Title
Adipocytokine plasma levels
Title
Adipocytokine adipose tissue expression
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Obesity
Exclusion Criteria:
Diabetes
Coronary heart disease
Eating disorders
Medication of beta blockers
Medication of antiobesity drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir Stich, Ass Prof MD PhD
Organizational Affiliation
Third Faculty of Medicine, Charles Uniersity in Prague
Official's Role
Principal Investigator
Facility Information:
Facility Name
Third Faculty of Medicine, Charles University in Prague
City
Prague
ZIP/Postal Code
100 00
Country
Czech Republic
12. IPD Sharing Statement
Links:
URL
http://www.lf3.cuni.cz
Description
web page of the Third Faculty of Medicine
Learn more about this trial
Role of Adipose Tissue in Pathogenesis of Insulin Resistance
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