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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01644942
First received: July 17, 2012
Last updated: June 17, 2013
Last verified: June 2013
  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
Hyperlipidemia
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:


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 ]

Enrollment: 33
Study Start Date: May 2008
Study Completion Date: June 2013
Primary Completion Date: June 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644942

Locations
France
CHRU Montpellier
Montpellier, France, 34295
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: June 17, 2013
Health Authority: France: Committee for the Protection of Personnes
France: 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:
Hyperlipidemias
Insulin Resistance
Obesity
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014