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

June 17, 2013 updated by: University Hospital, Montpellier

Identification in Obese Patients of the Mechanisms Involved in Intramuscular Lipid Accumulation.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHRU Montpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Insulin resistant patients
Other: Lipid accumulation analysis
The lipid accumulation will be assessed with muscular biopsies.
Other: Insulin sensitive patients
Other: Lipid accumulation analysis
The lipid accumulation will be assessed with muscular biopsies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
lipid accumulation in skeletal muscle
Time Frame: 1 month
1 month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

July 17, 2012

First Submitted That Met QC Criteria

July 17, 2012

First Posted (Estimate)

July 19, 2012

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 17, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8193

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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