BioAge: Biological Aging of Skeletal Muscles in Humans

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne (Other)
• Overall Status: Completed
• CT.gov ID: NCT02675192
• Collaborator: Ecole Nationale Superieure Lyon (Other), Institut National de la Recherche Agronomique (Other), Region Rhone Alpes (Other)
• Enrollment: 72
• Location: 1
• Actual Duration (Months): 15.1
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief Summary

Aging affects almost all the tissues and physiological functions, and skeletal muscle is the most affected organ. The progressive decline of the weight and the muscular function linked to the aging contributes to the lack of autonomy and dependence, but also to an increase of the mortality risks. Sarcopenia is also a prevalent condition, because it is detected in 13-24% of 60 years old, and 50% of 80 years old and more.

However, strong inter-individual variations of this prevalence of sarcopenia exists. The key issue is to understand why the biological aging of the skeletal muscle is so different between people.

In this study, mechanisms involved in biological aging of the skeletal muscle in aging people (same chronological age) will be specified.

Condition or Disease	Intervention/Treatment	Phase
HEALTHY	Other: Proof cohort : muscular assessment

Detailed Description

Aging affects almost all the tissues and physiological functions, and skeletal muscle is the most affected organ. The progressive decline of the weight and the muscular function linked to the aging contributes to the lack of autonomy and dependence, but also to an increase of the mortality risks. Sarcopenia is also a prevalent condition, because it is detected in 13-24% of 60 years old, and 50% of 80 years old and more.

However, strong inter-individual variations of this prevalence of sarcopenia exists. Some elderly (60 years old) reveal a biological aging of 80 years old, whereas 60 years old people reveal a biological aging of 60 years old. The key issue is to understand why the biological aging of the skeletal muscle is so different between people.

Previous sarcopenia studies in Humans did not really focus on chronological aging, they were all based on a comparison between young and old people. No study considered inter-individual modifications (biological aging) in sarcopenia. Furthermore, few studies were associated in the same study to "omic", histological, and epigenetic data, to obtain integrated point of view of Human Sarcopenia.

In this study, mechanisms involved in biological aging of the skeletal muscle in aging people (same chronological age) will be specified.

Study Design

• Study Type: Observational
• Actual Enrollment: 72 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Biological Aging of Skeletal Muscles in Humans, a Monocentric, Prospective Study
• Actual Study Start Date: Feb 18, 2016
• Actual Primary Completion Date: Jan 20, 2017
• Actual Study Completion Date: May 23, 2017

Arms and Interventions

Arm	Intervention/Treatment
Proof cohort : muscular assessment Clinical examination : Body weight, BMI, cardiac frequency, muscular examination,... Blood appraisal : glycaemia, lipidic appraisal, leptin, albumin, coagulation, metabolome and epigenetic tests,... Urinary collection : metabolome tests Maximal voluntary quadriceps strength (MVC) Checking muscle functional skills Muscular biopsy	Other: Proof cohort : muscular assessment; Clinical examination, blood appraisal, urinary collection, MVC, checking muscle functional skills and muscular biopsy will be performed.

Outcome Measures

Primary Outcome Measures

1. The area of type IIA fibers called vastus lateralis. [Day 15]

   The primary endpoint is the cross sectional area (measured in µm2) of type IIA fibers from the vastus lateralis muscle biopsies.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 80 Years to 83 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Belonging to the Proof cohort

• Between 80 and 83 years old

• Informed consent signed

• Genetic analyses consent signed

• Subject affiliated or entitled to a social security scheme

Exclusion Criteria:

• Anti coagulative treatment

• Severe obesity (>35)

• All chronic pathology requiring a treatment

• Severe renal insufficiency (discovery less than 6 months)

• Abnormal coagulation appraisal

• Allergy to local anesthetics

• Installation of a prosthetic hip and / or knee in the last six months

• Senile dementia

• Refusal of genetic study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Saint Etienne	Saint Etienne		France	42100

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Saint Etienne
• Ecole Nationale Superieure Lyon
• Institut National de la Recherche Agronomique
• Region Rhone Alpes

Investigators

• Principal Investigator: FEASSON Léonard, MD, CHU SAINT ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

• Barthélémy JC, Pichot V, Dauphinot V, Celle S, Laurent B, Garcin A, Maudoux D, Kerleroux J, Lacour JR, Kossovsky M, Gaspoz JM, Roche F. Autonomic nervous system activity and decline as prognostic indicators of cardiovascular and cerebrovascular events: the 'PROOF' Study. Study design and population sample. Associations with sleep-related breathing disorders: the 'SYNAPSE' Study. Neuroepidemiology. 2007;29(1-2):18-28.

• Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
• ClinicalTrials.gov Identifier: NCT02675192
• Other Study ID Numbers: 1508145; 2015-A01484-45
• First Posted: Feb 5, 2016
• Last Update Posted: Nov 17, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Centre Hospitalier Universitaire de Saint Etienne: sarcopenia; elderly; muscle biopsy

Study Results

No Results Posted as of Nov 17, 2021