NCT01644942

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started May 2008

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 18, 2013

Status Verified

June 1, 2013

Enrollment Period

5.1 years

First QC Date

July 17, 2012

Last Update Submit

June 17, 2013

Conditions

ObesityInsulin ResistanceHyperlipidemia

Keywords

Obeseinsulin sensitiveinsulin resistantmyotubeslipid accumulation

Outcome Measures

Primary Outcomes (1)

  • lipid accumulation in skeletal muscle

    1 month

Secondary Outcomes (1)

  • lipid accumulation in myotubes from obese patients

    1 month

Study Arms (2)

Insulin sensitive patients

OTHER
Other: Lipid accumulation analysis

Insulin resistant patients

OTHER
Other: Lipid accumulation analysis

Interventions

Lipid accumulation analysisOTHER

The lipid accumulation will be assessed with muscular biopsies.

Insulin resistant patientsInsulin sensitive patients

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

ObesityInsulin ResistanceHyperlipidemias

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesDyslipidemiasLipid Metabolism Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 19, 2012

Study Start

May 1, 2008

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 18, 2013

Record last verified: 2013-06

Locations

FR(1)