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Role of Adipose Tissue in Pathogenesis of Insulin Resistance

This study has been completed.
Sponsor:
Information provided by:
Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT00439491
First received: February 21, 2007
Last updated: NA
Last verified: February 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Obesity
Insulin Resistance
 Behavioral: Hypocaloric diet

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Role of Adipose Tissue in Pathogenesis of Insulin Resistance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:
  • Body weight
  • Body fat

Secondary Outcome Measures:
  • Insulin resistance
  • Adipocytokine plasma levels
  • Adipocytokine adipose tissue expression

Estimated Enrollment: 35
Study Start Date: January 2004
Estimated Study Completion Date: December 2006
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Obesity

Exclusion Criteria:

  • Diabetes
  • Coronary heart disease
  • Eating disorders
  • Medication of beta blockers
  • Medication of antiobesity drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00439491

Locations
Czech Republic
Third Faculty of Medicine, Charles University in Prague
Prague, Czech Republic, 100 00
Sponsors and Collaborators
Charles University, Czech Republic
Investigators
Principal Investigator: Vladimir Stich, Ass Prof MD PhD Third Faculty of Medicine, Charles Uniersity in Prague
  More Information

Additional Information:
web page of the Third Faculty of Medicine  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00439491     History of Changes
Other Study ID Numbers: 303040158
Study First Received: February 21, 2007
Last Updated: February 21, 2007
Health Authority: Czech Republic: Statní ustav pro kontrolu leciv

Keywords provided by Charles University, Czech Republic:
Obesity
Insulin resistance
Hypocaloric diet
Adipose tissue
adipocytokine

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013