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

Not Applicable

• Conditions: Obesity
• Interventions: Other: collection

• Registration Number: NCT03394469
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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.

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 Timeline

• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2018-01-08
• Study First Posted: 2018-01-09
• Study Start: 2018-06-04
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04
• Primary Completion: 2020-06-06
• Study Completion: 2020-06-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cohort	collection	Collection of clinical and paraclinical data (biological and anthropometric) for evaluation of sarcopenic obesity in obese patients.

Primary Outcome Measures

Name	Time	Method
Sarcopenia	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).

Trial Locations

Locations (1)

CHU Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France