Back to resultsBiological MArkers of FRAilty in Elderly Subjects (MAFRA)
Primary Purpose
Elderly Persons
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood collection
Sponsored by
About this trial
This is an interventional diagnostic trial for Elderly Persons
Eligibility Criteria
Inclusion Criteria:
- With social security coverage
- Accept to participate in the study and sign informed consent for the study and for the collection of biological samples
Exclusion Criteria:
- < 65 yo
Sites / Locations
- Chu de Reims
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
elderly subjects
Arm Description
Outcomes
Primary Outcome Measures
post-translational modification derived-products (PTMDP) quantification by Multidimensional Chromatography Coupled withTandem Mass Spectrometry (LC/LC-MS/MS)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02816580
Brief Title
Biological MArkers of FRAilty in Elderly Subjects
Acronym
MAFRA
Official Title
PTMDP (Post-translational Modification Derived Products) as Markers of Frailty in Elderly Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 23, 2015 (Actual)
Primary Completion Date
October 2, 2019 (Actual)
Study Completion Date
October 2, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elderly Persons
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
254 (Actual)
8. Arms, Groups, and Interventions
Arm Title
elderly subjects
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Blood collection
Primary Outcome Measure Information:
Title
post-translational modification derived-products (PTMDP) quantification by Multidimensional Chromatography Coupled withTandem Mass Spectrometry (LC/LC-MS/MS)
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
With social security coverage
Accept to participate in the study and sign informed consent for the study and for the collection of biological samples
Exclusion Criteria:
- < 65 yo
Facility Information:
Facility Name
Chu de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
12. IPD Sharing Statement
Learn more about this trial
Biological MArkers of FRAilty in Elderly Subjects
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