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SarcopeniaGERIASARCNCT03553147

Evaluation of the SARC-F Score as a Screening Tool for Undernutrition in a Geriatric Population

A study testing SARC-F score, handgrip test and impedancemetry in people with Sarcopenia and Denutrition, run by University Hospital, Clermont-Ferrand at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 70 years and olderHealthy volunteers can take part
Conditions the study is for
Sarcopenia, Denutrition
What is being tested?
SARC-F score, handgrip test and impedancemetry
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
1 siteFrance
Study dates
31 May 2018to 30 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 70 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Patrick LACARIN contact

0473751195

placarin@chu-clermontferrand.fr

France1 site, 1 recruiting

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003

    Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr

    Nicolas FARIGON

    Recruiting

Other trials in France

About this study

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

Read the detailed description

The geriatric population is a population at risk, given the frequent and numerous comorbidities present. Undernutrition is one of these, which is frequently associated with sarcopenia, that is, a decrease in muscle strength. Its screening must be early to avoid complications (osteoporosis, fractures, infections ...) and given the cost it generates for society. However, the detection of undernutrition can sometimes be time-consuming and its criteria in default, such as in the presence of edema or obesity, for example. There is a score, the SARC-F, which allows to detect sarcopenia from a result greater than or equal to 4, but which does not allow direct detection of undernutrition.

The primary objective is to evaluate the SARC-F score as a screening tool for undernutrition in a geriatric population, secondary objectives being to find a threshold value at this score, and also to estimate a prevalence of undernutrition in this population.

It will be a cross-sectional exploratory study to evaluate a diagnostic tool, the SARC-F score, with comparison between cases and controls.

The study will be conducted in a single center, a geriatric short-stay service. 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.

Being tested
SARC-F score, handgrip test and impedancemetry
Keywords
denutrition screening tool, SARC-F score, denutrition in geriatric population, sarc-f score associated with denutrition
Medical subject headings
Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SARC-F score, handgrip test and impedancemetryOther

    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.

Study groups in NCT03553147
Study groupRoleWhat they receive
Group/Cohort 1Experimentalall patient SARC-F score, handgrip test and impedancemetry
Receives: Other: SARC-F score, handgrip test and impedancemetry

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: at day 1

Secondary outcomes (2)

  1. SARC-F to predict undernutrition

    discriminant values of SARC-F to predict undernutrition in the study population, considered qualitatively or quantitatively

    Measured: at day 1

  2. denutrition prevalence

    overall prevalence of undernutrition in the study population

    Measured: at day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2018
  2. Study start31 May 2018
  3. Primary completion30 Apr 2019 (estimated)
  4. Study completion30 Sep 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03553147
Sponsor's protocol ID
CHU-390
Other IDs
2017-A03050-53
Acronym
GERIASARC
Status last verified
Feb 2019
First submitted
29 May 2018
Last updated
4 Feb 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25799486

  • 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.

    PubMed 27381508

  • 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.

    PubMed 18395429

  • 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.

    PubMed 20392703

  • 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.

    PubMed 28095426

  • 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.

    PubMed 28145950

  • 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.

    PubMed 28012107

  • 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.

    PubMed 27066316

  • 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.

    PubMed 3558716

Questions about this trial

What is this clinical trial studying?

A study testing SARC-F score, handgrip test and impedancemetry in people with Sarcopenia and Denutrition, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Patrick LACARIN (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

score SARC-F (time frame: at day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03553147, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2019.

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