We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01644942
First Posted: July 19, 2012
Last Update Posted: June 18, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Montpellier
  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: None (Open Label)
Official Title: Identification in Obese Patients of the Mechanisms Involved in Intramuscular Lipid Accumulation.

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • lipid accumulation in skeletal muscle [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • lipid accumulation in myotubes from obese patients [ Time Frame: 1 month ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644942


Locations
France
CHRU Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
  More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01644942     History of Changes
Other Study ID Numbers: 8193
First Submitted: July 17, 2012
First Posted: July 19, 2012
Last Update Posted: June 18, 2013
Last Verified: June 2013

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

Additional relevant MeSH terms:
Insulin Resistance
Hyperlipidemias
Hyperlipoproteinemias
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs