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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644942
• Other study ID #: 8193
• Status: Completed
• Phase: N/A
• First received: July 17, 2012
• Last updated: June 17, 2013
• Start date: May 2008
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hyperlipidemia
• Hyperlipidemias
• Insulin Resistance
• Obesity

Intervention

Other:
• Lipid accumulation analysis
The lipid accumulation will be assessed with muscular biopsies.

Locations

Country	Name	City	State
France	CHRU Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lipid accumulation in skeletal muscle		1 month	No
Secondary	lipid accumulation in myotubes from obese patients		1 month	No