Relationships Between Quality of Ageing and Age-related Degenerated Disease (Compalimage)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University Hospital, Clermont-Ferrand.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Centre de Recherche en Nutrition Humaine d'Auvergne
Institut National de la Recherche Agronomique
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00862615
First received: March 12, 2009
Last updated: September 28, 2010
Last verified: September 2010
  Purpose

This project aims to assess the impact of chronic micro-inflammation on age-related loss of muscle (sarcopenia) and bone (osteopenia). The hypothesis is that chronic micro-inflammation and oxidative stress, which prevalence increases during ageing, may participate in the pathogenesis of both sarcopenia and osteopenia.


Condition Intervention
Age-related Degenerated Disease
Other: Measurement of muscle protein synthesis using stable isotopes and muscle biopsies.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Chronic Micro-inflammation and Bone and Muscular Status in Elderly

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • Isotopic enrichments in expired gas, in plasma cetoisocaproate and in free or protein-bound leucine in muscle will be measured to determine proteolysis and proteosynthesis rate of muscle proteins. [ Time Frame: at week 0 and week 6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Splanchnic extraction of amino acids, bone metabolism, muscular strength, global metabolism and quality of life. [ Time Frame: at week 0 and week 6 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 32
Study Start Date: January 2009
Estimated Study Completion Date: January 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Measurement of muscle protein synthesis using stable isotopes and muscle biopsies.

    Measurement of muscle protein synthesis using stable isotopes and muscle biopsies.

    Isotopes are :

    (13C)bicarbonate (0.09 mg/kg fat-free mass) and L(1-13C)leucine (1.3 mg/kg fat-free mass) (intravenous way) L-(5,5,5 2H3) leucine(0.09 µmoles/(kg de fat-free mass.min) (oral way)

Detailed Description:

In order to explore the effect of a moderate chronic inflammation on skeletal muscle function and protein metabolism and on bone status, two groups of 16 subjects each will be selected according to their inflammatory status ie non-inflamed versus micro-inflamed. The volunteers will be sampled twice at week 0 and week 6 in order to quantify plasma concentration of C reactive protein (CRP) using the ultra sensitive assay. The subjects exhibiting CRP lower than 1 mg/l twice will be included in the non-inflamed group and the subjects exhibiting CRP higher than 3 and lower than 15 mg/l will be included in the micro-inflamed group.

During the two weeks before the metabolic studies dietary intakes, DEXA, muscle function, VO2 max and biomarkers of bone remodelling will be assessed. Volunteers will then be submitted to a diet controlled for its protein content, for 4 days (1 g protein/kg/day and 30 kcal/kg/day) before metabolic investigations. One day before, urine will be collected for metabolomics. On the day of metabolic investigations, after an overnight fast, blood samples will be collected for albumin, fibrinogen, inflammatory cytokine and adipokine determination. Then, the subjects will be perfused with L-[1-13C] leucine for 8 hours (post absorptive sate then post prandial satte) during which expired gas and blood samples will be taken, as well as 2 muscle biopsies. Isotopic enrichments in expired gas, in plasma cetoiscaproate and in free or protein-bound leucine in muscle will be measured to determine proteolysis and proteosynthesis rate of muscle proteins.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male
  • Body mass index 21 BMI 30 kg/m2
  • Affiliated to National Health Insurance
  • Subject giving his written informed consent
  • Subject considered as normal after clinical examination and medical questionnaire.

Exclusion Criteria:

  • Positive serologies to HIV or HCV, determined on blood samples
  • Previous medical and/or surgery judged by the investigator as incompatible with this study
  • Chronic pathologies : Diabetes, cardiovascular diseases, cancer, chronic inflammation diseases, renal, pulmonary impairments Reported xylocaïne allergy
  • Osteoporosis
  • Prostate hypertrophy
  • Glaucoma
  • Heavy consumer of alcohol
  • Practising intensive physical exercise
  • Being under someone's supervision
  • Refusal to be registered on the National Volunteers Data file
  • Dietary habits unreliable to controlled food intake
  • Being in exclusion on the National Volunteers Data file
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00862615

Contacts
Contact: Patrick Lacarin 04.73.75.11.95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick Lacarin    04.73.75.11.95    placarin@chu-clermont-ferrand.fr   
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Centre de Recherche en Nutrition Humaine d'Auvergne
Institut National de la Recherche Agronomique
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Noël CANO University Hospital, Clermont-Ferrand
Study Director: Dominique Dardevet Institut National de la Recherche Agronomique
  More Information

No publications provided

Responsible Party: Noël CANO, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00862615     History of Changes
Other Study ID Numbers: CHU-0048, IDRCB 2008-A00593-52, AU750
Study First Received: March 12, 2009
Last Updated: September 28, 2010
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:
Ageing
Inflammation
Muscle protein synthesis
Osteopenia
Sarcopenia

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on April 21, 2014