Abdominal Adiposity and Muscle Mitochondrial Functions (Mithycal)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yves Boirie, Institut National de la Recherche Agronomique
ClinicalTrials.gov Identifier:
NCT00446745
First received: March 9, 2007
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

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?

Condition
Mitochondrial Respiratory Chain Deficiencies

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Interaction Between Adipose and Muscle Tissues in the Control of Muscle Mitochondrial Functions

Resource links provided by NLM:


Further study details as provided by Institut National de la Recherche Agronomique:

Enrollment: 60
Study Start Date: April 2006
Study Completion Date: January 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts
Abdominal obesity
60 males were recruited according to waist circumference, from lean to obese values

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)

  Eligibility

Ages Eligible for Study:   35 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00446745

Locations
France
Centre ed Recherche en Nutrition Humaine d'Auvergne (CRNH), Unité d'Exploration Nutritionnelle, Laboratoire de Nutrition humaine
Clermont Ferrand, France, 63009 cedex 1
Sponsors and Collaborators
Institut National de la Recherche Agronomique
Investigators
Principal Investigator: Yves Boirie, PU-PH UMR1019 INRA - Auvergne University
Study Director: Beatrice Morio, PhD UMR 1019 INRA - Auvergne University
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Yves Boirie, Prof., Institut National de la Recherche Agronomique
ClinicalTrials.gov Identifier: NCT00446745     History of Changes
Other Study ID Numbers: AU628
Study First Received: March 9, 2007
Last Updated: September 18, 2012
Health Authority: France: Ministry of Health

Keywords provided by Institut National de la Recherche Agronomique:
Nutritional and Metabolic Diseases
Insulin resistance
Energy Metabolisms
Skeletal muscle
Visceral Adipose Tissue

Additional relevant MeSH terms:
Mitochondrial Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on October 19, 2014