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Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrome; CLINical Study

Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrome; CLINical Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04238494
Acronym
MIDAS
Enrollment
60
Registered
2020-01-23
Start date
2019-10-18
Completion date
2022-05-30
Last updated
2021-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Frail Elderly Syndrome

Keywords

imaging, myosteatosis (Myosteatosis is the pathologic accumulation of lipid that can occur in conjunction with atrophy and fibrosis following skeletal muscle injury)

Brief summary

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.

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.

Interventions

DIAGNOSTIC_TESTNuclear magnetic resonance (NMR)

Muscle architecture, lipid and active tissue muscle content should be measured. Proton NMR imaging (MRI)

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Multicomponent assessment: clinical, biological, functional, cognitive and MRI (muscle and brain)

Eligibility

Sex/Gender
ALL
Age
70 Years to 90 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Fat involution and trophicity in rectus femorisday 1percentage 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)

Secondary

MeasureTime frameDescription
description of brain by MRIday 1description 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.
Evaluation of inflammation gradeday 1description 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
measure the myostatin rateday 1To explore the role of Myostatin in the regulation loop of muscle function during frailty
measure the cystatin-C and creatinine rateday 1Determine the associations between muscle alterations seen on MRI and glomerular filtration rate estimated using serum cystatin-C or creatinine
measure the serum interleukin IL-1b and IL-18 rateday 1Determine the associations between muscle alterations seen on MRI and serum IL-1b and IL-18.

Countries

France

Contacts

Primary ContactIsabelle BOURDEL-MARCHASSON, MD,PhD
isabelle.bourdel-marchasson@chu-bordeaux.fr+33 (0)5 57 65 65 71
Backup ContactFara RATSIMBAZAFY
fara.ratsimbazafy@chu-bordeaux.fr+33(0)5 57 65 65 71

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026