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

NCT03394469 | Unknown

• 2 other identifiers: CHU-3662017-A01510-53.
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Sarcopenia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

cohort

OTHER

Collection of clinical and paraclinical data (biological and anthropometric) for evaluation of sarcopenic obesity in obese patients.

Other: collection

Interventions

collection OTHER

Blood, urinary and faecal samples

cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Obesity; Sarcopenia

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Study Officials

• Yves BOIRIE

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

0473751195; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2017
• First Posted: January 9, 2018
• Study Start: June 4, 2018
• Primary Completion: June 6, 2020
• Study Completion: June 6, 2020
• Last Updated: February 4, 2019

Record last verified: 2019-02

Locations

FR (1)