Obesity and OverweightOBESAR-2NCT06880432
Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Cohort of Adult Obese Patients and Longitudinal Follow-up
A study testing Collection of fluid samples in people with Obesity and Overweight, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- Collection of fluid samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2025to Dec 2039
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand
Yves BOIRIE, 0473752330, yboirie@chu-clermontferrand.fr
About this study
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.
Read more
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
- Being tested
- Collection of fluid samples
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of fluid samplesOther
- Blood sampling, urine sampling and tissue sampling
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Other | Collection of clinical and paraclinical data (biological and anthropometric) for evaluation of sarcopenic obesity in obese patients. Receives: Other: Collection of fluid samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the prevalence of sarcopenia in a population of adult subjects with obesity, at baseline and at 5 and 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.
Measured: Day 1 / 5 years /10 years
Secondary outcomes (11)
% of patients with the factors associated with sarcopenia
Study the factors associated with sarcopenia by considering the clinical and biological characteristics of obese patients.
Measured: Day 1 / 5 years /10 years
concentration of biomarkers in a group of obese patients with sarcopenia using the biobank.
Identify plasma, serum, genetic and urinary biomarkers in a group of obese patients with sarcopenia using the biobank.
Measured: Day 1 / 5 years /10 years
Evaluate the degree of severity of sarcopenic obesity over time using the ESPEN/EASO consensus staging system.
Measured: Day 1 / 5 years /10 years
% change of parameters measured to identify the group at risk of accelerated decline
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
Measured: 5 years /10 years
% of evolution of biomarkers
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.
Measured: Day 1 / 5 years /10 years
% of risk of various health problems (diabetes, hypertension, etc.) between sarcopenic and non-sarcopenic patients.
Study the risk of various health problems (diabetes, hypertension, etc.) between sarcopenic and non-sarcopenic patients.
Measured: Day 1 / 5 years /10 years
% of patients with the factors associated with sarcopenia in the subgroup of patients undergoing bariatric surgery.
Study the factors associated with sarcopenia by considering the clinical and biological characteristics of obese patients.
Measured: 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.
Identify plasma, serum, genetic and urinary biomarkers in a group of obese patients with sarcopenia using the biobank.
Measured: 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.
Measured: 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.
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.
Measured: 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.
Study the risk of various health problems (diabetes, hypertension, etc.) between sarcopenic and non-sarcopenic patients.
Measured: Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionDec 2039 (estimated)
- Study completionDec 2039 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves BOIRIE, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880432
- Sponsor's protocol ID
- RBHP 2024 BOIRIE
- Acronym
- OBESAR-2
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06880432
- Acronym / sponsor ID
- OBESAR-2 / RBHP 2024 BOIRIE
- Conditions
- Obesity and Overweight
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Dec 2039 (estimated)
- Study completion
- Dec 2039 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | Other | Other: Collection of fluid samplesCollection of clinical and paraclinical data (biological and anthropometric) for evaluation of sarcopenic obesity in obese patients. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of fluid samples- Blood sampling, urine sampling and tissue sampling | Other | Cohort |
Primary outcome
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.
11 secondary outcomes
% of patients with the factors associated with sarcopenia
Time frame: 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
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
% change of parameters measured to identify the group at risk of accelerated decline
Time frame: 5 years /10 years
% of evolution of biomarkers
Time frame: 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
% 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]
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]
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]
% 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
% 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]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yves BOIRIE principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of fluid samples in people with Obesity and Overweight, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.