NCT00446745

Brief Summary

Numerous studies have demonstrated that excess perivisceral adipose tissue is associated with metabolic diseases such as insulin resistance. In skeletal muscle, insulin resistance has been correlated with reduced mitochondrial oxidative functions. According to the actual theory, mitochondrial dysfunctions are proposed to play a causal role in the aetiology of insulin resistance. Mechanisms involve increased intramyocellular lipids storage. Yet, the causes responsible for the decline in muscle mitochondrial functions remain to be elucidated. The investigators hypothesize that these alterations are induced by combined changes in plasma profiles of lipids and adipokines, which originate from perivisceral adipose tissue. The study aims at answering the following questions :

  • Are muscle mitochondrial functions altered in association with increased perivisceral adipose tissue storage?
  • Do changes in the pattern of plasma lipids and adipokines explain this correlation?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2006

Shorter than P25 for all trials

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

April 1, 2006

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2007

Completed
Last Updated

September 19, 2012

Status Verified

September 1, 2012

Enrollment Period

8 months

First QC Date

March 9, 2007

Last Update Submit

September 18, 2012

Conditions

Keywords

Nutritional and Metabolic DiseasesInsulin resistanceEnergy MetabolismsSkeletal muscleVisceral Adipose Tissue

Study Arms (1)

Abdominal obesity

60 males were recruited according to waist circumference, from lean to obese values

Eligibility Criteria

Age35 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

* 60 Male subjects * Age between 35 and 50 * waist circumference (Waist) \> 75 cm 15 men with Waist between 75 and \<87cm, 15 men with Waist between 87 and \<94cm, 15 men with Waist between 94 and \<102cm, and 15 men with Waith equal or higher than 102cm.

You may qualify if:

  • Male subjects
  • Age between 35 and 50
  • waist circumference \> 75 cm
  • Baecke score \< 1 (activity score for sedentary subjects)
  • Subjects giving written informed consent
  • Subjects willing to comply with the study procedures
  • Subjects considered as normal after clinical examination and medical questionnaire

You may not qualify if:

  • Weight change \> 3 kg within 3 months prior to study
  • Patients with type 1 or type 2 diabetes
  • Serologic evidence of active hepatitis B or HIV
  • History of cancer or significant intestinal, hepatic, renal or cardiovascular disorders within the past 5 years
  • History of systemic infections or inflammatory diseases within the past 2 months
  • Hypocaloric or special diets (e.g. vegetarian)
  • Patients currently known to abuse or to be dependent on any drug, including alcohol (daily consumption \> 20g) and tobacco (daily consumption \> 5 cigarettes)
  • CRP \< 5 mg/L
  • Blood coagulation disorders
  • Allergy to xylocaïne
  • for test meal : Food allergy (particularly milk allergy and lactose intolerance)
  • for MRI : Claustrophobia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre ed Recherche en Nutrition Humaine d'Auvergne (CRNH), Unité d'Exploration Nutritionnelle, Laboratoire de Nutrition humaine

Clermont-Ferrand, 63009 cedex 1, France

Location

Related Publications (3)

  • Chanseaume E, Tardy AL, Salles J, Giraudet C, Rousset P, Tissandier A, Boirie Y, Morio B. Chronological approach of diet-induced alterations in muscle mitochondrial functions in rats. Obesity (Silver Spring). 2007 Jan;15(1):50-9. doi: 10.1038/oby.2007.511.

    PMID: 17228031BACKGROUND
  • Chanseaume E, Malpuech-Brugere C, Patrac V, Bielicki G, Rousset P, Couturier K, Salles J, Renou JP, Boirie Y, Morio B. Diets high in sugar, fat, and energy induce muscle type-specific adaptations in mitochondrial functions in rats. J Nutr. 2006 Aug;136(8):2194-200. doi: 10.1093/jn/136.8.2194.

    PMID: 16857840BACKGROUND
  • Chanseaume E, Barquissau V, Salles J, Aucouturier J, Patrac V, Giraudet C, Gryson C, Duche P, Boirie Y, Chardigny JM, Morio B. Muscle mitochondrial oxidative phosphorylation activity, but not content, is altered with abdominal obesity in sedentary men: synergism with changes in insulin sensitivity. J Clin Endocrinol Metab. 2010 Jun;95(6):2948-56. doi: 10.1210/jc.2009-1938. Epub 2010 Apr 9.

MeSH Terms

Conditions

Mitochondrial DiseasesNutritional and Metabolic DiseasesInsulin Resistance

Condition Hierarchy (Ancestors)

Metabolic DiseasesHyperinsulinismGlucose Metabolism Disorders

Study Officials

  • Yves Boirie, PU-PH

    UMR1019 INRA - Auvergne University

    PRINCIPAL INVESTIGATOR
  • Beatrice Morio, PhD

    UMR 1019 INRA - Auvergne University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

March 9, 2007

First Posted

March 13, 2007

Study Start

April 1, 2006

Primary Completion

December 1, 2006

Study Completion

January 1, 2007

Last Updated

September 19, 2012

Record last verified: 2012-09

Locations