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

October 19, 2021 updated by: University Hospital, Bordeaux

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

Recruiting

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

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Limoges, France, 87000
        • Not yet recruiting
        • Service de Médecine Gériatrique, CHU de LIMOGES
        • Contact:
        • Contact:
        • Principal Investigator:
          • Achilla THCALLA, MD,PhD
      • Pessac, France, 33604

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

70 years to 90 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Isabelle BOURDEL-MARCHASSON, MD, PhD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2019

Primary Completion (Anticipated)

May 30, 2022

Study Completion (Anticipated)

May 30, 2022

Study Registration Dates

First Submitted

August 19, 2019

First Submitted That Met QC Criteria

January 22, 2020

First Posted (Actual)

January 23, 2020

Study Record Updates

Last Update Posted (Actual)

October 20, 2021

Last Update Submitted That Met QC Criteria

October 19, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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