Sarcopenic Obesity: Estimation of Prevalence and Identifi... | NCT03394469

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

NCT03394469

Sponsor

University Hospital, Clermont-Ferrand

Status

Unknown status

Last Update Posted

Feb 4, 2019Actual

Enrollment

800Estimated

Phase

Not Applicable

Conditions

Obesity

Interventions

collection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2017-A01510-53.	Other Identifier	2017-A01510-53.

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 4, 2018Actual

Primary Completion Date

Jun 6, 2020Estimated

Completion Date

Jun 6, 2020Estimated

First Submitted Date

Nov 16, 2017

First Submission Date that Met QC Criteria

Jan 8, 2018

First Posted Date

Jan 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2019

Last Update Posted Date

Feb 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cohort	Other	Collection of clinical and paraclinical data (biological and anthropometric) for evaluation of sarcopenic obesity in obese patients.	Other: collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
collection	Other	Blood, urinary and faecal samples	cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Patrick LACARIN	Contact	0473751195		placarin@chu-clermontferrand.fr

Overall Officials

Name	Affiliation	Role
Yves BOIRIE	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Clermont-Ferrand	Recruiting	Clermont-Ferrand		63003	France

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D055948	Sarcopenia

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided