Mediating Role of Myokines in the Dialogue Between Muscle and Bone Tissue in a Population of Healthy Women Aged 20-89 Years

NCT06683222 | Recruiting

• 1 other identifier: AO12022/2023/VB-01
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 2

Brief Summary

The main hypothesis is that muscle acts on bone tissue via the secretion of myokines (myostatin, follistatin, irisin). This is based on previous results showing that muscle mass in different patient populations with very different body mass indexes (anorexic or obese patients) is significantly and independently associated with bone mineral density.

Conditions

Bone Density

Keywords

Myokines

Outcome Measures

Primary Outcomes (5)

• Myostatin

  Plasma concentration of myostatin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay

  Baseline

• Follistatin

  Plasma concentration of follistatin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay

  Baseline

• Irisin

  Plasma concentration of irisin will be measured in pg/ml by Enzyme-Linked Immuno Sorbent Assay

  Baseline

• Bone Mineral Density

  Bone densitometry using X-ray absorptiometry (DXA) measured in g/cm²

  Baseline

• Lean body mass

  Impedencemetry, measured in Kg

  Baseline

Secondary Outcomes (18)

• Leptin

  Baseline

• Adiponecotin

  Baseline

• Fat mass

  Baseline

• Bone mineral density: impedencemetry

  Baseline

• Grip test

  Baseline

Other Outcomes (2)

• Creation of a blood bank

  Baseline

• Creation of a saliva bank

  Baseline

Study Arms (1)

Sub-group of 280 patients derived from the MONIKA study

OTHER

Diagnostic Test: Blood sample; Diagnostic Test: Saliva sample; Diagnostic Test: Grip test; Other: MicroFET2® maximum isometric force test; Other: Maximum isometric knee extension bench test.; Other: The SPPB (Short Physical Performance Battery); Other: The 6-minute walking test.; Other: Segmental impedancemetry examination.; Other: Indirect calorimetry test.; Other: Fardellone's questionnaire; Other: ONAPS questionnaire; Other: Dietary intake.questionnaire

Interventions

Blood sample DIAGNOSTIC_TEST

36 ml of blood in 3 x 7 ml dry tubes, 1 x 5 ml EDTA tube, 1 x 5 ml heparinized tube, 1 x 5 ml anti-protease tube)

Sub-group of 280 patients derived from the MONIKA study

Saliva sample DIAGNOSTIC_TEST

5 ml of saliva will be taken.

Sub-group of 280 patients derived from the MONIKA study

Grip test DIAGNOSTIC_TEST

The grip strength of the dominant arm will be measured with the participant in a standing position, with the arm close to the body and the elbow at 90◦ flexion, while the non-dominant arm will be positioned alongside the body. Three measurements will be taken for the dominant hand, and the mean value will be calculated and used for analysis. One minute is allowed between each repetition, to avoid muscle fatigue. Dynamometer quality control is ensured by regularly checking known resistance values.

Sub-group of 280 patients derived from the MONIKA study

MicroFET2® maximum isometric force test OTHER

The microFET2 device is used to test isometric force. The microFET2 dynamometer is battery-powered and ergonomically designed to fit in the palm of the hand. The system is microprocessor-controlled to provide accurate, repeatable muscle force readings. The microFET Clinical software automatically performs calculations and validity tests, and allows graphs to be generated from the data, enabling reports of different patient tests to be compared

Sub-group of 280 patients derived from the MONIKA study

Maximum isometric knee extension bench test. OTHER

The maximal isometric knee extension strength test on a specially-adapted strength bench consists in performing 3 maximal contractions with 1 minute's rest between each test.

Sub-group of 280 patients derived from the MONIKA study

The SPPB (Short Physical Performance Battery) OTHER

Battery of tests comprising a balance test, a walking speed test and a chair-lift test

Sub-group of 280 patients derived from the MONIKA study

The 6-minute walking test. OTHER

Muscular function will be determined by the 6-minute walk test to assess aerobic endurance. Participants will be asked to walk for 6 min as fast as possible on a shuttle track. The distance (m) covered in 6 min will be measured. Walking speed (m/s) will be calculated as the distance (m) covered in 6 min. A walking speed \<0.8 m/s has been defined as a low value.

Sub-group of 280 patients derived from the MONIKA study

Segmental impedancemetry examination. OTHER

Segmental impedancemetry involves measuring body composition using the body's resistance to the passage of a low-intensity electric current. This test is harmless to the body.

Sub-group of 280 patients derived from the MONIKA study

Indirect calorimetry test. OTHER

An Indirect calorimetry is the standard method for measuring energy expenditure at rest. It is based on the principle that the human body burns nutrients using O2 and producing CO2.

Sub-group of 280 patients derived from the MONIKA study

Fardellone's questionnaire OTHER

Completion of a questionnaires on calcium intake (Fardellone)

Sub-group of 280 patients derived from the MONIKA study

ONAPS questionnaire OTHER

The ONAPS questionnaire contains questions on physical activity and sedentariness

Sub-group of 280 patients derived from the MONIKA study

Dietary intake.questionnaire OTHER

The dietary intake questionnaire contains questions regarding the person's eating habits - how many meals a day, where they eat, whether they eat alone, what foods they eat/drink and whether they are following a particular diet and, if so, the reasons why.

Sub-group of 280 patients derived from the MONIKA study

Eligibility Criteria

• Age: 20 Years - 89 Years
• Gender Eligibility Details: Female patients only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-reported Caucasian ethnicity (Europe, Middle East, North Africa) only as there is a difference in BMD by ethnicity.
• Person affiliated with or benefiting from a social security scheme.

You may not qualify if:

• Fragility fracture defined as a spontaneous or low-kinetic fracture (≤ one fall from height).
• Early menopause (\< 40 years), hysterectomy (complete \< 40 years), primary amenorrhea (absence of menstruation before 15 years), current amenorrhea of more than 3 months without contraceptive if the patient is less than 40 years old.
• Patients on treatments: prolonged corticosteroid therapy \> 3 months or \> 1 g (cumulative dose).
• Immobilization of more than 3 months, less than 12 months old.
• Hip fracture in a first-degree relative.
• Patients with any of the following pathologies affecting bone, muscle or adipose tissue:
• Inflammatory bowel disease (IBD: Crohn's disease, ulcerative colitis) and untreated celiac disease.
• Renal insufficiency on dialysis or patients with nephrology follow-up.
• Known hypercalciuria.
• Osteomalacia, rickets, osteogenesis imperfecta.
• Osteopathy (Paget's disease, osteopetrosis, etc.).
• Chronic inflammatory rheumatism.
• Hemopathy, neoplasia.
• Hepatic insufficiency or chronic hepatitis.
• Endocrinopathy: diabetes, dysthyroidism, hypogonadism, hypercorticism, untreated acromegaly.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

C.H.R.U. Lapeyronie

Montpellier, 34295, France

RECRUITING

Chu Nimes

Nîmes, 30029, France

RECRUITING

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Thibault MURA, Prof.

  Centre Hospitalier Universitaire de Nīmes

  STUDY DIRECTOR

Central Study Contacts

Vincent BOUDOUSQ, Dr

CONTACT

+334.66.68.32.66; vincent.boudousq@chu-nimes.fr

Anissa MEGZARI

CONTACT

0466684236; drc@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The cohort will be a sub-group derived from the 425 healthy female volunteers who will be recruited for the MONIKA study. For the MONIKA study, we expect around 350 to be recruited at the Nîmes and Montpellier sites. Among these women recruited at the Nîmes and Montpellier sites, 280 participants will be invited to take part in the MyOs study.

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 12, 2024
• Study Start: November 6, 2024
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)