Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-29 @ 7:35 AM
Study NCT ID:
NCT06880432
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-17
First Post:
2025-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Cohort of Adult Obese Patients and Longitudinal Follow-up
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OBESAR-2
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: