NCT00439491

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2004

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2007

Completed
Last Updated

February 23, 2007

Status Verified

February 1, 2007

First QC Date

February 21, 2007

Last Update Submit

February 21, 2007

Conditions

ObesityInsulin Resistance

Keywords

ObesityInsulin resistanceHypocaloric dietAdipose tissueadipocytokine

Outcome Measures

Primary Outcomes (2)

  • Body weight

  • Body fat

Secondary Outcomes (3)

  • Insulin resistance

  • Adipocytokine plasma levels

  • Adipocytokine adipose tissue expression

Interventions

Hypocaloric dietBEHAVIORAL

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Obesity

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third Faculty of Medicine, Charles University in Prague

Prague, 100 00, Czechia

Location

Related Links

MeSH Terms

Conditions

ObesityInsulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Vladimir Stich, Ass Prof MD PhD

    Third Faculty of Medicine, Charles Uniersity in Prague

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2007

First Posted

February 23, 2007

Study Start

January 1, 2004

Study Completion

December 1, 2006

Last Updated

February 23, 2007

Record last verified: 2007-02

Locations

CZ(1)