Identification in Obese Patients of the Mechanism Involve... | NCT01644942

Studies
Identification in Obese Patients of the Mechanism Involved in Intramuscular Lipid Accumulation

NCT01644942

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Jun 18, 2013Estimated

Enrollment

33Actual

Phase

Not Applicable

Conditions

Obesity
Insulin Resistance
Hyperlipidemia

Interventions

Lipid accumulation analysis

Countries

France

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

Jun 2013

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

May 2008

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Jul 17, 2012

First Submission Date that Met QC Criteria

Jul 17, 2012

First Posted Date

Jul 19, 2012Estimated

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

Jun 17, 2013

Last Update Posted Date

Jun 18, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aims to determine in obese patients the implication of intramuscular lipid accumulation in relation with insulin resistance and defect in lipid oxidation.

Detailed Description

Obese insulin sensitive and obese insulin resistant patients undergo a glucose tolerance test, indirect calorimetry during exercise and muscular biopsy.

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

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Insulin sensitive patients	Other		Other: Lipid accumulation analysis
Insulin resistant patients	Other		Other: Lipid accumulation analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lipid accumulation analysis	Other	The lipid accumulation will be assessed with muscular biopsies.	Insulin resistant patients Insulin sensitive patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
lipid accumulation in skeletal muscle		1 month

Secondary Outcomes

Measure	Description	Time Frame
lipid accumulation in myotubes from obese patients		1 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Obese patients with a Body Mass Index (BMI) between 30 and 40 kg/m2
Patients who do not practice physical exercise (Voorips index < 9)
Age between 40 and 70 years- Male gender
Fast blood glucose <1,10 g/l and no hypoglycemic treatment
Signed informed consent
Social security affiliation
Absence of anti VIH, anti hepatitis C antibodies, and HBS antigen
Normal biological tests
Non smoking persons

Exclusion Criteria:

Patients who refuse the anti-VIH, anti-hepatitis C antibodies, and HBS antigens tests
Patients treated by anticoagulant, b blockers, lipopenic, or anti-inflammatory.
Patients with a contraindication to muscular exercise (retinopathy, coronaropathy, nephropathy) and to muscular biopsy
Allergy to local anaesthetic

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU Montpellier		Montpellier		34295	France

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D007333	Insulin Resistance
D006949	Hyperlipidemias

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided