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

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
collection
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Obesity focused on measuring Obesity, Sarcopenia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

cohort

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
November 16, 2017
Last Updated
February 1, 2019
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03394469
Brief Title
Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Population of Adult Obese Patients
Acronym
OBESAR
Official Title
Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Population of Adult Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 4, 2018 (Actual)
Primary Completion Date
June 6, 2020 (Anticipated)
Study Completion Date
June 6, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Sarcopenia

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
No masking
Allocation
N/A
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cohort
Arm Type
Other
Arm Description
Collection of clinical and paraclinical data (biological and anthropometric) for evaluation of sarcopenic obesity in obese patients.
Intervention Type
Other
Intervention Name(s)
collection
Intervention Description
Blood, urinary and faecal samples
Primary Outcome Measure Information:
Title
Sarcopenia
Description
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).
Time Frame
at day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves BOIRIE
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
0473751195
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Yves BOIRIE

12. IPD Sharing Statement

Learn more about this trial

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

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