Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Cohort of Adult Obese Patients and Longitudinal Follow-up

NCT ID: NCT06880432

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2039-12-31

Brief Summary

Context: Obesity, defined as excessive body fat, can lead to disability and loss of autonomy. If there is concomitant quantitative and qualitative muscle loss, sarcopenic obesity (SO) is suspected in this context. Although this clinical entity was defined several years ago, it is only very recently that precise assessment criteria have been established for screening and diagnosing this pathology (Donini et al. 2022).

Defined by the ESPEN/EASO consensus, SO has various consequences for health, particularly in terms of mobility and worsening of co-morbidities. It is therefore necessary to screen for SO, to determine its prevalence in the general population and to identify the determining factors in the loss of muscle mass during obesity. Most studies on the prevalence of sarcopenic obesity focus on the elderly population, bearing in mind that the prevalence of this syndrome in the elderly will increase rapidly as a result of the shift in the incidence of obesity from adults to this population in the coming decades.

The aim of this project is to determine the prevalence and determining or predisposing factors for sarcopenic obesity in a population of obese people in a broad age range (18-70 years).

Longitudinal follow-up of this cohort is planned in order to assess multifactorial changes (body composition, muscle function and physical performance) at 5 and 10 years after their inclusion in the OBESAR-2 study. In addition, patients who have undergone bariatric surgery will also be followed in the shorter term to analyse the phenotypic changes induced by rapid weight loss on muscle loss.

Conditions

Obesity and Overweight

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Cohort

Collection of clinical and paraclinical data (biological and anthropometric) for evaluation of sarcopenic obesity in obese patients.

Group Type: OTHER

Collection of fluid samples

Intervention Type: OTHER

\- Blood sampling, urine sampling and tissue sampling

Interventions

Collection of fluid samples

\- Blood sampling, urine sampling and tissue sampling

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age: 18-70
• Sex: men and women
• Clinical nutrition patient receiving a metabolic assessment to optimise clinical and paraclinical management
• Patient meeting obesity criteria defined by BMI > 30 kg/m².
• Patient of legal age who has given free, informed and signed consent
• Patient covered by social security

• Patients with cancer or severe chronic disease (renal failure, respiratory failure, liver failure)
• Patients with neuromuscular disease
• Patient with total walking disability
• Patients who are minors
• Patient refusing to take part in the study
• Pregnant or breast-feeding women
• Under guardianship, curatorship, deprived of liberty or under court protection
• Patient who has taken part in the OBESAR study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yves BOIRIE

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Countries

France

Central Contacts

Lise Laclautre

Role: CONTACT

promo_interne_drci@chu-clermontferrand.fr

334.73.754.963

Facility Contacts

Yves BOIRIE

Role: primary

yboirie@chu-clermontferrand.fr

0473752330

Other Identifiers

RBHP 2024 BOIRIE

Identifier Type: -

Identifier Source: org_study_id