NCT03553147

Brief Summary

To study the relationship between sarcopenia and undernutrition in adult patients over 70 years of age, and at the same time to define a threshold value for the predictive SARC-F score of undernutrition. Hypothesis : the SARC-F score is correlated with malnutrition defined according to the following HAS criteria : Moderate denutrition Severe denutrition

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 29, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

May 31, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 12, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

May 29, 2018

Last Update Submit

February 1, 2019

Conditions

Keywords

denutrition screening toolSARC-F scoredenutrition in geriatric populationsarc-f score associated with denutrition

Outcome Measures

Primary Outcomes (1)

  • score SARC-F

    SARC-F score (dependent variable) defined by a questionnaire, completed by the patient during the stay at the clinic. This questionnaire includes 5 questions rated from 0 to 2 and is therefore 10 in total. It is admitted the presence of sarcopenia for a score greater than or equal to 4 according to the literature. However, there is currently no study defining a threshold for the diagnosis of undernutrition

    at day 1

Secondary Outcomes (2)

  • SARC-F to predict undernutrition

    at day 1

  • denutrition prevalence

    at day 1

Study Arms (1)

Group/Cohort 1

EXPERIMENTAL

all patient SARC-F score, handgrip test and impedancemetry

Other: SARC-F score, handgrip test and impedancemetry

Interventions

Participation in the study will be offered to any patient admitted to the geriatric ward, those who meet the inclusion criteria and do not have exclusion criteria will have to complete the SARC-F questionnaire during their stay, and to do the handgrip test and impedancemetry performed by a third party. Biological data (albumin, pre-albumin and C-Reactive Protein) and anthropometric data will be collected and analyzed to determine if the patient is malnourished or not, and the results of SARC-F will be compared between these 2 groups.

Group/Cohort 1

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • years and over
  • living at home or in nursing homes in Puy-de-Dôme
  • sent in short geriatric stay at the Grand Pré clinic by their general practioner, an emergency department or an EHPAD

You may not qualify if:

  • refusal to participate in the study
  • severe dementia preventing answering SARC-F questions
  • no fluency in the French language
  • patient with a pacemaker (contraindication of the use of impedancemetry)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Related Publications (9)

  • Cederholm T, Bosaeus I, Barazzoni R, Bauer J, Van Gossum A, Klek S, Muscaritoli M, Nyulasi I, Ockenga J, Schneider SM, de van der Schueren MA, Singer P. Diagnostic criteria for malnutrition - An ESPEN Consensus Statement. Clin Nutr. 2015 Jun;34(3):335-40. doi: 10.1016/j.clnu.2015.03.001. Epub 2015 Mar 9.

    PMID: 25799486BACKGROUND
  • Delliere S, Cynober L. Is transthyretin a good marker of nutritional status? Clin Nutr. 2017 Apr;36(2):364-370. doi: 10.1016/j.clnu.2016.06.004. Epub 2016 Jun 20.

    PMID: 27381508BACKGROUND
  • Zamboni M, Mazzali G, Fantin F, Rossi A, Di Francesco V. Sarcopenic obesity: a new category of obesity in the elderly. Nutr Metab Cardiovasc Dis. 2008 Jun;18(5):388-95. doi: 10.1016/j.numecd.2007.10.002. Epub 2008 Apr 18.

    PMID: 18395429BACKGROUND
  • Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

    PMID: 20392703BACKGROUND
  • Beaudart C, Zaaria M, Pasleau F, Reginster JY, Bruyere O. Health Outcomes of Sarcopenia: A Systematic Review and Meta-Analysis. PLoS One. 2017 Jan 17;12(1):e0169548. doi: 10.1371/journal.pone.0169548. eCollection 2017.

    PMID: 28095426BACKGROUND
  • Deren ME, Babu J, Cohen EM, Machan J, Born CT, Hayda R. Increased Mortality in Elderly Patients with Sarcopenia and Acetabular Fractures. J Bone Joint Surg Am. 2017 Feb 1;99(3):200-206. doi: 10.2106/JBJS.16.00734.

    PMID: 28145950BACKGROUND
  • Ethgen O, Beaudart C, Buckinx F, Bruyere O, Reginster JY. The Future Prevalence of Sarcopenia in Europe: A Claim for Public Health Action. Calcif Tissue Int. 2017 Mar;100(3):229-234. doi: 10.1007/s00223-016-0220-9. Epub 2016 Dec 24.

    PMID: 28012107BACKGROUND
  • Malmstrom TK, Miller DK, Simonsick EM, Ferrucci L, Morley JE. SARC-F: a symptom score to predict persons with sarcopenia at risk for poor functional outcomes. J Cachexia Sarcopenia Muscle. 2016 Mar;7(1):28-36. doi: 10.1002/jcsm.12048. Epub 2015 Jul 7.

    PMID: 27066316BACKGROUND
  • Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40(5):373-83. doi: 10.1016/0021-9681(87)90171-8.

    PMID: 3558716BACKGROUND

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Nicolas FARIGON

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

May 29, 2018

First Posted

June 12, 2018

Study Start

May 31, 2018

Primary Completion

April 30, 2019

Study Completion

September 30, 2019

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations