NCT02816580

Brief Summary

Epidemiological data from Europe have shown that around 30% of subjects aged over 65 years of age are pre-frail, and 15% are frail. Recent research has demonstrated that identifying frailty and implementing preventive measures can help to slow cognitive decline. Screening and treating frailty seem to be a good start towards preventing dependency. On the premise that this frailty is the result of more pronounced tissue alterations in certain elderly subjects, assessment of post-translational modification derived products (PTMDP) represents an innovative evaluation method. These include advanced glycation end-products (AGE), and carbamylation-derived products (homocitrulline). Indeed, the intensity of these modifications increases with ageing, and assessing the products resulting from these alterations could show the existence of differences according to frailty status. This would make it possible to adapt treatment accordingly in elderly subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
254

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 23, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 28, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2019

Completed
Last Updated

January 21, 2026

Status Verified

February 1, 2022

Enrollment Period

4.6 years

First QC Date

June 17, 2016

Last Update Submit

January 19, 2026

Conditions

Elderly Persons

Outcome Measures

Primary Outcomes (1)

  • post-translational modification derived-products (PTMDP) quantification by Multidimensional Chromatography Coupled withTandem Mass Spectrometry (LC/LC-MS/MS)

    baseline

Study Arms (1)

elderly subjects

EXPERIMENTAL
Other: Blood collection

Interventions

Blood collectionOTHER
elderly subjects

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • With social security coverage
  • Accept to participate in the study and sign informed consent for the study and for the collection of biological samples

You may not qualify if:

  • \- \< 65 yo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Reims

Reims, 51092, France

Location

Related Publications (1)

  • Mahmoudi R, Jaisson S, Badr S, Jaidi Y, Bertholon LA, Novella JL, Gillery P. Post-translational modification-derived products are associated with frailty status in elderly subjects. Clin Chem Lab Med. 2019 Jul 26;57(8):1153-1161. doi: 10.1515/cclm-2018-1322.

    PMID: 30817296BACKGROUND

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2016

First Posted

June 28, 2016

Study Start

February 23, 2015

Primary Completion

October 2, 2019

Study Completion

October 2, 2019

Last Updated

January 21, 2026

Record last verified: 2022-02

Locations

FR(1)