- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04238494
Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrome; CLINical Study (MIDAS)
Frailty is a multideterminant syndrome in which muscle function appears to play a central role. Muscle function depends on brain control, nutrition and perfusion. We hypothesized that multiparametric MRI assessment combined with comprehensive gerontological assessment (CGA) and routine biological assessment of inflammation in a sample of older people with and without diabetes will allow to explore on one side the possibilities of multi-parametric MRI muscle and brain imaging to describe the correlates of frailty and on the other side will describe the different muscle/brain alterations due to diabetes in frailty.
The main objective is to compare the lipid percent of the rectus femoris in frail and pre-frail older subjects and in non-frail older subjects.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Frailty concept has been created to screen the older people at risk for dependency and to propose preventive intervention. Muscle function is at the centre of the concept and the majority of interventions proposed to reverse or to prevent frailty have targeted physical function. Anatomical and functional alteration of muscle, called sarcopenia is defined as a low skeletal muscle mass, a decrease in strength (dynapenia or sarcopenia is the age-associated loss of muscle strength that is not caused by neurologic or muscular diseases) and functional consequences such as low gait speed. Qualitative analysis should be associated with quantitative (mass) analysis in older subjects assessed for frailty. Muscle architecture, lipid and active tissue muscle content should be measured. Proton NMR imaging (MRI) can be used for this purpose. Brain changes were also reported to be associated with frailty. The study of structural changes associated with brain MRI alterations may better explain the frailty process.
Robust, frail and pre-frail subjects will be compared for clinical and MRI data. Grey matter volumes, white matter hyperintensities, diffusion tensor imaging data and muscle assessments relationships will be described After baseline assessment follow-up will be performed by phone calls after one month and after six months to record the number of falls and severity, the number of unscheduled hospitalization, the admission in institution for older people and death.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Isabelle BOURDEL-MARCHASSON, MD,PhD
- Phone Number: +33 (0)5 57 65 65 71
- Email: isabelle.bourdel-marchasson@chu-bordeaux.fr
Study Contact Backup
- Name: Fara RATSIMBAZAFY
- Phone Number: +33(0)5 57 65 65 71
- Email: fara.ratsimbazafy@chu-bordeaux.fr
Study Locations
-
-
-
Limoges, France, 87000
- Not yet recruiting
- Service de Médecine Gériatrique, CHU de LIMOGES
-
Contact:
- Achille THCALLA, MD,PhD
- Phone Number: +335 55 05 55 55
- Email: achille.tchalla@unilim.fr
-
Contact:
- Caroline GAYOT
- Phone Number: +335 55 05 69 57
- Email: Caroline.Gayot@chu-limoges.fr
-
Principal Investigator:
- Achilla THCALLA, MD,PhD
-
Pessac, France, 33604
- Recruiting
- Service de gériatrie - CHU Bordeaux - hôpital Xavier Arnozan
-
Contact:
- Isabelle Bourdel-Marchasson, MD, PhD
- Phone Number: 05 57 65 65 71
- Email: isabelle.bourdel-marchasson@chu-bordeaux.fr
-
Contact:
- Fara RATSIMBAZAFY
- Phone Number: 05 57 65 65 71
- Email: fara.ratsimbazafy@chu-bordeaux.fr
-
Principal Investigator:
- Isabelle Bourdel-Marchasson, MD,PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Robust or frail or pre-frail with at least 25% frail and 25% pre-frail according to Frieds criteria
- Barthel index > or = 60/100
- With or without diabetes mellitus, 45 to 55 % with known diabetes mellitus
- With no contraindication to undergo an MRI examination
Exclusion Criteria:
- not willing to participate
- not able to give informed consent or to understand basic instruction due to any problem (sensorial, educational, language)
- without social insurance
- with a legal protection
- with significant cognitive alteration (MMSe<21/30 or in case of low literacy <19/30)
- with a recent (2 month period) severe event: hospitalization, sepsis, stroke even with complete recovery, trauma
- with stroke sequelae (motor, speech)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Frail/prefrail
Fried's criteria >3 = frail, 1 or 2 = prefrail The 5 Fried criteria mainly target the muscle function: low muscle strength, decreased physical activity and low gait speed.
One refers to depressive symptoms with the use of 2 CES-D (Centre for Epidemiologic Studies - Depression Scale) questions and one to nutrition with the weight loss criteria.
The second most famous definition of frailty was developed by ROCKWOOD and MITNISIKI (2).
It describes frailty as the accumulation of deficits including cognitive, functional and social alterations
|
Muscle architecture, lipid and active tissue muscle content should be measured.
Proton NMR imaging (MRI)
|
Other: non frail
No Fried's criteria
|
Muscle architecture, lipid and active tissue muscle content should be measured.
Proton NMR imaging (MRI)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fat involution and trophicity in rectus femoris
Time Frame: day 1
|
percentage of the rectus femoris lipid of both leg (dominant and non-dominant) in frail and pre-frail older subject and in non-frail older subjects (MRI with T1)
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
description of brain by MRI
Time Frame: day 1
|
description of MRI brain correlates of frailty and assessment of their sensibility / specificity with regards to Fried's frailty syndrome in a population older than 70y with at least 25% of subjects frail and 25% pre-frail and none with high level of daily living dependency.
|
day 1
|
Evaluation of inflammation grade
Time Frame: day 1
|
description of muscle/brain MRI correlates of frailty and assessment of their sensibility / specificity with regards to Fried's frailty syndrome in a population with low/medium grade inflammation (HsCRP>3mg/L), older than 70y as compared to other subjects
|
day 1
|
measure the myostatin rate
Time Frame: day 1
|
To explore the role of Myostatin in the regulation loop of muscle function during frailty
|
day 1
|
measure the cystatin-C and creatinine rate
Time Frame: day 1
|
Determine the associations between muscle alterations seen on MRI and glomerular filtration rate estimated using serum cystatin-C or creatinine
|
day 1
|
measure the serum interleukin IL-1b and IL-18 rate
Time Frame: day 1
|
Determine the associations between muscle alterations seen on MRI and serum IL-1b and IL-18.
|
day 1
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Isabelle BOURDEL-MARCHASSON, MD, PhD, University Hospital, Bordeaux
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2019/09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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