Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Cohort of Adult Obese Patients and Longitudinal Follow-up (OBESAR-2)

March 11, 2025 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Cohort
Collection of clinical and paraclinical data (biological and anthropometric) for evaluation of sarcopenic obesity in obese patients.
Other: Collection of fluid samples
- Blood sampling, urine sampling and tissue sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To estimate the prevalence of sarcopenia in a population of adult subjects with obesity, at baseline and at 5 and 10 years.
Time Frame: Day 1 / 5 years /10 years

The primary endpoint is the presence of sarcopenic obesity at inclusion, 5 years and 10 years post-inclusion, assessed according to the latest current recommendations, i.e. impaired muscle function and impaired body composition (Donini et al. 2022).

A patient presents with sarcopenic obesity when there is an alteration in muscle function AND an alteration in body composition.

For impaired muscular function, strength measured with the handgrip is considered pathological when it is less than 27kg for men and less than 16kg for women.

Altered body composition is considered to exist when fat mass is greater than 39, 41 and 43% for women aged between 20 and 39, 40 and 59, and 60 and 79 respectively, and greater than 26, 29 and 31% for men aged between 20 and 39, 40 and 59, and 60 and 79 respectively, AND SMM/W (Skeletal Muscle Mass/Weight) is less than 37% in men and 27.6% in women.
Day 1 / 5 years /10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
% of patients with the factors associated with sarcopenia
Time Frame: Day 1 / 5 years /10 years
Study the factors associated with sarcopenia by considering the clinical and biological characteristics of obese patients.
Day 1 / 5 years /10 years
concentration of biomarkers in a group of obese patients with sarcopenia using the biobank.
Time Frame: Day 1 / 5 years /10 years
Identify plasma, serum, genetic and urinary biomarkers in a group of obese patients with sarcopenia using the biobank.
Day 1 / 5 years /10 years
Evaluate the degree of severity of sarcopenic obesity over time using the ESPEN/EASO consensus staging system.
Time Frame: Day 1 / 5 years /10 years
Day 1 / 5 years /10 years
% change of parameters measured to identify the group at risk of accelerated decline
Time Frame: 5 years /10 years
Evaluate 5- and 10-year trends in anthropometric measurements, muscle function, metabolic parameters and body composition to estimate the group at risk of accelerated decline
5 years /10 years
% of evolution of biomarkers
Time Frame: Day 1 / 5 years /10 years
Evaluate changes in plasma, serum, genetic and urinary biomarkers in the same population 5 and 10 years after the inclusion visit, and assess the relationship between changes in biomarkers and changes in sarcopenia using the biobank.
Day 1 / 5 years /10 years
% of risk of various health problems (diabetes, hypertension, etc.) between sarcopenic and non-sarcopenic patients.
Time Frame: Day 1 / 5 years /10 years
Study the risk of various health problems (diabetes, hypertension, etc.) between sarcopenic and non-sarcopenic patients.
Day 1 / 5 years /10 years
% of patients with the factors associated with sarcopenia in the subgroup of patients undergoing bariatric surgery.
Time Frame: Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]
Study the factors associated with sarcopenia by considering the clinical and biological characteristics of obese patients.
Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]
concentration of biomarkers in a group of obese patients with sarcopenia using the biobank in the subgroup of patients undergoing bariatric surgery.
Time Frame: Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]
Identify plasma, serum, genetic and urinary biomarkers in a group of obese patients with sarcopenia using the biobank.
Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]
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.
Time Frame: Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]
Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]
% of evolution of biomarkers in the subgroup of patients undergoing bariatric surgery.
Time Frame: Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years
Evaluate changes in plasma, serum, genetic and urinary biomarkers in the same population 5 and 10 years after the inclusion visit, and assess the relationship between changes in biomarkers and changes in sarcopenia using the biobank.
Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years
% of risk of various health problems (diabetes, hypertension, etc.) between sarcopenic and non-sarcopenic patients in the subgroup of patients undergoing bariatric surgery.
Time Frame: Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]
Study the risk of various health problems (diabetes, hypertension, etc.) between sarcopenic and non-sarcopenic patients.
Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Yves Boirie, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

December 1, 2039

Study Completion (Estimated)

December 1, 2039

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RBHP 2024 BOIRIE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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