search
Back to results

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
Charles University, Czech Republic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring Obesity, Insulin resistance, Hypocaloric diet, Adipose tissue, adipocytokine

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

First Posted
February 21, 2007
Last Updated
February 21, 2007
Sponsor
Charles University, Czech Republic
search

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

We'll reach out to this number within 24 hrs