Abdominal Adiposity and Muscle Mitochondrial Functions

NCT ID: NCT00446745

Last Updated: 2012-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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?

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mitochondrial Respiratory Chain Deficiencies

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Nutritional and Metabolic Diseases Insulin resistance Energy Metabolisms Skeletal muscle Visceral Adipose Tissue

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Abdominal obesity

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yves Boirie

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yves Boirie, PU-PH

Role: PRINCIPAL_INVESTIGATOR

UMR1019 INRA - Auvergne University

Beatrice Morio, PhD

Role: STUDY_DIRECTOR

UMR 1019 INRA - Auvergne University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Clermont-Ferrand, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17228031 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16857840 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20382691 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AU628

Identifier Type: -

Identifier Source: org_study_id