Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Population of Adult Obese Patients

Obesity Clinical Trial

— OBESAR  

Official title:

Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Population of Adult Obese Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03394469
• Other study ID #: CHU-366
• Secondary ID: 2017-A01510-53.
• Status: Recruiting
• Phase: N/A
• Start date: June 4, 2018
• Est. completion date: June 6, 2020

Study information

• Verified date: February 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 0473751195
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: June 6, 2020
• Est. primary completion date: June 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• collection
Blood, urinary and faecal samples

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	at day 1