- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03394469
Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Population of Adult Obese Patients (OBESAR)
February 1, 2019 updated by: University Hospital, Clermont-Ferrand
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.
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
800
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 Locations
-
-
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Clermont-Ferrand, France, 63003
- Recruiting
- CHU Clermont-Ferrand
-
-
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
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
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.
|
Blood, urinary and faecal samples
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
at day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (ACTUAL)
June 4, 2018
Primary Completion (ANTICIPATED)
June 6, 2020
Study Completion (ANTICIPATED)
June 6, 2020
Study Registration Dates
First Submitted
November 16, 2017
First Submitted That Met QC Criteria
January 8, 2018
First Posted (ACTUAL)
January 9, 2018
Study Record Updates
Last Update Posted (ACTUAL)
February 4, 2019
Last Update Submitted That Met QC Criteria
February 1, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-366
- 2017-A01510-53. (OTHER: 2017-A01510-53.)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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