Variation in Body Composition on the Fate of Older Subjec... | NCT04464278

Studies
Variation in Body Composition on the Fate of Older Subjects During SSR Hospitalization

NCT04464278

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Unknown status

Last Update Posted

Jul 9, 2020Actual

Enrollment

360Estimated

Phase

Not provided

Conditions

Body Weight Changes

Interventions

Not provided

Countries

Not provided

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
IDRCB 2019-A03287-50	Other Identifier	ANSM

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2020Estimated

Primary Completion Date

Oct 2023Estimated

Completion Date

Oct 2023Estimated

First Submitted Date

Jun 8, 2020

First Submission Date that Met QC Criteria

Jul 8, 2020

First Posted Date

Jul 9, 2020Actual

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

Jul 8, 2020

Last Update Posted Date

Jul 9, 2020Actual

Name	Class
INSERM UMR S 1136	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of this study is to correlate weight variation as well as body composition with mortality and unscheduled readmission of geriatric population

Detailed Description

Weight loss in obese adults confers health benefits, while weight loss in the elderly is associated with an increased risk of mortality.

There are a large number of studies associating weight loss and mortality but the relationships between changes in body composition (ratio between fat mass and lean mass) and mortality are often contradictory and poorly understood in elderly subject. The aim at this study is to request at this question.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

360Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The prognosis value of variation of weight on mortality	Determination of variation of weight between D0 and D21 after inclusion	3 months
Mortality rate	Monitoring of survival at 3 months after inclusion	3 months

Secondary Outcomes

Measure	Description	Time Frame
The pprognosis value of variation of weight on unscheduled readmission in SSR	Determination of variation of weight between D0 and D21 after inclusion	Between D0 and D21
Unscheduled readmission in SSR

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient ≥70 years old
Hospitalized in SSR for less than 7 days
No patient opposition

Exclusion Criteria:

patient with a pacemaker
lake of nutritional assessment on admission
lake of assessment of autonomy at admission
Patient under guardianship or curatorship
Patient participating in another clinical research
Patient for whom a short stay (<21 days) is planned in SSR

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

70 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Geriatric population hospitalized in geriatric department at Rothschild and Emile-Roux hospitals

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christine FORASASSI, MD	Contact	01 40 19 34 14		christine.forasassi@aphp.fr
Christian AUSSEL, MD	Contact	01 40 19 34 00		christian.aussel@aphp.fr

Overall Officials

Name	Affiliation	Role
Christine FORASASSI, MD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001836	Body Weight Changes

Ancestor Terms

ID	Term
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Case group: weight loss ≥ 5%
Control group: weight loss ≤ 5%