Role of Adipose Tissue in Pathogenesis of Insulin Resistance | NCT00439491

Studies
Role of Adipose Tissue in Pathogenesis of Insulin Resistance

NCT00439491

Sponsor

Charles University, Czech Republic

Status

Completed

Last Update Posted

Feb 23, 2007Estimated

Enrollment

Phase

Not Applicable

Conditions

Obesity
Insulin Resistance

Interventions

Hypocaloric diet

Countries

Czechia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2004

Primary Completion Date

Not provided

Completion Date

Dec 2006

First Submitted Date

Feb 21, 2007

First Submission Date that Met QC Criteria

Feb 21, 2007

First Posted Date

Feb 23, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 21, 2007

Last Update Posted Date

Feb 23, 2007Estimated

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Hypocaloric diet	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body weight
Body fat

Secondary Outcomes

Measure	Description	Time Frame
Insulin resistance
Adipocytokine plasma levels
Adipocytokine adipose tissue expression

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Obesity

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vladimir Stich, Ass Prof MD PhD	Third Faculty of Medicine, Charles Uniersity in Prague	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Third Faculty of Medicine, Charles University in Prague		Prague		100 00	Czechia

Label	URL
web page of the Third Faculty of Medicine	View source

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided