Abdominal Adiposity and Muscle Mitochondrial Functions (Mithycal)

September 18, 2012 updated by: Yves Boirie, Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Study of Interaction Between Adipose and Muscle Tissues in the Control of Muscle Mitochondrial Functions

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?

Study Overview

Status

Completed

Conditions

Detailed Description

Sixty 35 to 50-years old sedentary men will be included based on their abdominal circumference (from 75 to over 102 cm).

Body composition will be evaluated using dual-energy X-ray absorptiometry and perivisceral, intramuscular and intrahepatic adiposity will be assess by MRI and proton-NMR spectroscopy. Subjects will be also characterized by their glucose tolerance (OGTT), basal metabolism (indirect calorimetry) and maximal oxygen consumption (maximal aerobic power test on exercise bike).

Blood samples will be collected in the fasted state to assess lipids and adipokines concentrations.

Biopsies will be obtained from the vastus lateralis muscle to examine mitochondrial functions (respiration rates, ATP and superoxide anion production rates, maximal activity of oxidative enzyme). Gene expression of key enzymes, protein and transcription factors involved in lipid and energy metabolism will be assessed using real-time quantitative PCR.

Finally, whole body and muscle protein metabolism will be investigated in half of the subjects using tracer infusion (incorporation of L-[1-13C]leucine) and biopsies from vastus lateralis, both in the post-absorptive and post-prandial states (test meal)

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont Ferrand, France, 63009 cedex 1
        • Centre ed Recherche en Nutrition Humaine d'Auvergne (CRNH), Unité d'Exploration Nutritionnelle, Laboratoire de Nutrition humaine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Abdominal obesity
60 males were recruited according to waist circumference, from lean to obese values

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement

Investigators

  • Principal Investigator: Yves Boirie, PU-PH, UMR1019 INRA - Auvergne University
  • Study Director: Beatrice Morio, PhD, UMR 1019 INRA - Auvergne University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

March 9, 2007

First Submitted That Met QC Criteria

March 9, 2007

First Posted (Estimate)

March 13, 2007

Study Record Updates

Last Update Posted (Estimate)

September 19, 2012

Last Update Submitted That Met QC Criteria

September 18, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AU628

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mitochondrial Respiratory Chain Deficiencies

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe