ObesityOBESARNCT03394469
Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Population of Adult Obese Patients
A study testing collection in people with Obesity, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
This project aims first to determine the prevalence of sarcopenia in a population of obese people of extended age group (18-70 years). In a second step, the factors determining and / or predisposing to sarcopenic obesity will be identified as well as plasmatic and urinary biomarkers specific to this phenotype. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- collection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2018to 6 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years
- Sex: men and women
- Patient followed in clinical nutrition benefiting from a metabolic assessment for optimization of clinical and paraclinical management
- Patient meeting the criteria of obesity defined by BMI> 30 kg / m²
- Major patient with free, informed and signed consent
- Patient covered by the social security scheme
Who cannot join
- Patient with cancer or severe chronic disease (renal failure, respiratory failure, liver failure)
- Patient with neuromuscular disease
- Patient with a total inability to walk
- Minor patient
- Refusal of the patient to participate in the study
- Pregnant or lactating women
- Patient deprived of liberty or under guardianship.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr
Yves BOIRIE
About this study
This project aims first to determine the prevalence of sarcopenia in a population of obese people of extended age group (18-70 years). In a second step, the factors determining and / or predisposing to sarcopenic obesity will be identified as well as plasmatic and urinary biomarkers specific to this phenotype.
Read the detailed description
Collection of clinical and paraclinical data (biological and anthropometric) for evaluation of sarcopenic obesity in obese patients.
Biological collection to identify plasma, serum, genetic, urinary and faecal biomarkers associated with sarcopenic obesity
- Conditions
- Obesity
- Being tested
- collection
- Keywords
- Obesity, Sarcopenia
- Medical subject headings
- Obesity, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collectionOther
Blood, urinary and faecal samples
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sarcopenia
The primary endpoint is sarcopenia (present / absent), defined using the muscle mass index (SMI) corresponding to = SM / Height², where the total muscle mass (SM) is calculated from validated equations. by Janssen et al in a population of men and women with a large age range (18-86 years) and adiposity (BMI: 16-48 kg / m integrating bio-impedancemetry data ( BIA).
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start4 Jun 2018
- Primary completion6 Jun 2020 (estimated)
- Study completion6 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 800 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
- NCT03394469
- Sponsor's protocol ID
- CHU-366
- Other IDs
- 2017-A01510-53.
- Acronym
- OBESAR
- Status last verified
- Feb 2019
- First submitted
- 16 Nov 2017
- Last updated
- 4 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. 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 Population of Adult Obese Patients
- ClinicalTrials.gov ID
- NCT03394469
- Acronym / sponsor ID
- OBESAR / CHU-366
- Conditions
- Obesity
- Keywords
- Obesity, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 6 Jun 2020 (estimated)
- Study completion
- 6 Jun 2020 (estimated)
- First posted
- 9 Jan 2018 (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.
This project aims first to determine the prevalence of sarcopenia in a population of obese people of extended age group (18-70 years). In a second step, the factors determining and / or predisposing to sarcopenic obesity will be identified as well as plasmatic and urinary biomarkers specific to this phenotype.
Detailed description
Collection of clinical and paraclinical data (biological and anthropometric) for evaluation of sarcopenic obesity in obese patients.
Biological collection to identify plasma, serum, genetic, urinary and faecal biomarkers associated with sarcopenic obesity
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: collectionCollection 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 (6 listed)
- Age: 18-70 years
- Sex: men and women
- Patient followed in clinical nutrition benefiting from a metabolic assessment for optimization of clinical and paraclinical management
- Patient meeting the criteria of obesity defined by BMI> 30 kg / m²
- Major patient with free, informed and signed consent
Key exclusion criteria (7 listed)
- Patient with cancer or severe chronic disease (renal failure, respiratory failure, liver failure)
- Patient with neuromuscular disease
- Patient with a total inability to walk
- Minor patient
- Refusal of the patient to participate in the study
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 |
|---|---|---|
| collectionBlood, urinary and faecal samples | Other | cohort |
Primary outcome
Sarcopenia
Time frame: at day 1
The primary endpoint is sarcopenia (present / absent), defined using the muscle mass index (SMI) corresponding to = SM / Height², where the total muscle mass (SM) is calculated from validated equations. by Janssen et al in a population of men and women with a large age range (18-86 years) and adiposity (BMI: 16-48 kg / m integrating bio-impedancemetry data ( BIA).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2019.
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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. This study is not recruiting at the moment.
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 in people with Obesity, 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 4 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sarcopenia (time frame: at day 1). 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 4 Feb 2019.