Clinical trial NCT06880432: Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Cohort of Adult Obese Patients and Longitudinal Follow-up
Official title: Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Cohort of Adult Obese Patients and Longitudinal Follow-up
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity and Overweight
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


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

Non-inclusion criteria :

* 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

Primary outcomes:
measure: To estimate the prevalence of sarcopenia in a population of adult subjects with obesity, at baseline and at 5 and 10 years.
timeFrame: Day 1 / 5 years /10 years
Secondary outcomes:
measure: % of patients with the factors associated with sarcopenia
timeFrame: Day 1 / 5 years /10 years
measure: concentration of biomarkers in a group of obese patients with sarcopenia using the biobank.
timeFrame: Day 1 / 5 years /10 years
measure: Evaluate the degree of severity of sarcopenic obesity over time using the ESPEN/EASO consensus staging system.
timeFrame: Day 1 / 5 years /10 years
measure: % change of parameters measured to identify the group at risk of accelerated decline
timeFrame: 5 years /10 years
measure: % of evolution of biomarkers
timeFrame: Day 1 / 5 years /10 years
measure: % of risk of various health problems (diabetes, hypertension, etc.) between sarcopenic and non-sarcopenic patients.
timeFrame: Day 1 / 5 years /10 years
measure: % of patients with the factors associated with sarcopenia in the subgroup of patients undergoing bariatric surgery.
timeFrame: Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]
measure: concentration of biomarkers in a group of obese patients with sarcopenia using the biobank in the subgroup of patients undergoing bariatric surgery.
timeFrame: Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]
measure: Evaluate the degree of severity of sarcopenic obesity over time using the ESPEN/EASO consensus staging system in the subgroup of patients undergoing bariatric surgery.
timeFrame: Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]
measure: % of evolution of biomarkers in the subgroup of patients undergoing bariatric surgery.
timeFrame: Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years
measure: % of risk of various health problems (diabetes, hypertension, etc.) between sarcopenic and non-sarcopenic patients in the subgroup of patients undergoing bariatric surgery.
timeFrame: Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Yves BOIRIE
role: PRINCIPAL_INVESTIGATOR
References: