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

This study is currently recruiting participants.
Verified July 2012 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01644942
First received: July 17, 2012
Last updated: NA
Last verified: July 2012
History: No changes posted
  Purpose

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


Condition Intervention
Obesity
Insulin Resistance
Lipid Accumulation
 Other: Lipid accumulation analysis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Identification in Obese Patients of the Mechanisms Involved in Intramuscular Lipid Accumulation.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • lipid accumulation in skeletal muscle [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • lipid accumulation in myotubes from obese patients [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment: 21
Study Start Date: May 2008
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Insulin sensitive patients Other: Lipid accumulation analysis
The lipid accumulation will be assessed with muscular biopsies.
Insulin resistant patients Other: Lipid accumulation analysis
The lipid accumulation will be assessed with muscular biopsies.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644942

Contacts
Contact: Jacques Mercier, MD, PhD (33) 4 67 33 82 84 j-mercier@chu-montpellier.fr

Locations
France
CHRU Montpellier Recruiting
Montpellier, France, 34000
Contact: Jacques Mercier, MD, PhD     (33) 4 67 33 82 84     j-mercier@chu-montpellier.fr    
Principal Investigator: Jacques Mercier, MD, PhD            
Sponsors and Collaborators
University Hospital, Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01644942     History of Changes
Other Study ID Numbers: 8193
Study First Received: July 17, 2012
Last Updated: July 17, 2012
Health Authority: France: Committee for the Protection of Personnes
France: L’Agence nationale de sécurité du médicament et des produits de santé

Keywords provided by University Hospital, Montpellier:
Obese
insulin sensitive
insulin resistant
myotubes
lipid accumulation

Additional relevant MeSH terms:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013