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NCT00439491 Clinical Trial

Role of Adipose Tissue in Pathogenesis of Insulin Resistance

Obesity Clinical Trial

Official title:
Role of Adipose Tissue in Pathogenesis of Insulin Resistance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00439491
Other study ID # 303040158
Secondary ID
Status Completed
Phase N/A
First received February 21, 2007
Last updated February 21, 2007
Start date January 2004
Est. completion date December 2006

Study information
Verified date February 2007
Source Charles University, Czech Republic
Contact n/a
Is FDA regulated No
Health authority Czech Republic: Statní ustav pro kontrolu leciv
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Obesity

Exclusion Criteria:

- Diabetes

- Coronary heart disease

- Eating disorders

- Medication of beta blockers

- Medication of antiobesity drugs

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Behavioral:
• Hypocaloric diet

Locations
Country Name City State
Czech Republic Third Faculty of Medicine, Charles University in Prague Prague

Sponsors (1)
Lead Sponsor Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czech Republic, 

Outcome
Type Measure Description Time frame Safety issue
Primary Body weight
Primary Body fat
Secondary Insulin resistance
Secondary Adipocytokine plasma levels
Secondary Adipocytokine adipose tissue expression
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