Role of Adipose Tissue in Pathogenesis of Insulin Resistance

February 21, 2007 updated by: Charles University, Czech Republic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Prague, Czech Republic, 100 00
        • Third faculty of medicine, Charles University in Prague

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Obesity

Exclusion Criteria:

  • Diabetes
  • Coronary heart disease
  • Eating disorders
  • Medication of beta blockers
  • Medication of antiobesity drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Body weight
Body fat

Secondary Outcome Measures

Outcome Measure
Insulin resistance
Adipocytokine plasma levels
Adipocytokine adipose tissue expression

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Investigators

  • Principal Investigator: Vladimir Stich, Ass Prof MD PhD, Third Faculty of Medicine, Charles Uniersity in Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion

December 7, 2022

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

February 21, 2007

First Submitted That Met QC Criteria

February 21, 2007

First Posted (Estimate)

February 23, 2007

Study Record Updates

Last Update Posted (Estimate)

February 23, 2007

Last Update Submitted That Met QC Criteria

February 21, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 303040158

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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