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

Primary Purpose

Frail Elderly Syndrome, Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Nuclear magnetic resonance (NMR)
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Frail Elderly Syndrome focused on measuring imaging, myosteatosis (Myosteatosis is the pathologic accumulation of lipid that can occur in conjunction with atrophy and fibrosis following skeletal muscle injury)

Eligibility Criteria

70 Years - 90 Years (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Service de Médecine Gériatrique, CHU de LIMOGES
  • Service de gériatrie - CHU Bordeaux - hôpital Xavier ArnozanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Frail/prefrail

non frail

Arm Description

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

No Fried's criteria

Outcomes

Primary Outcome Measures

Fat involution and trophicity in rectus femoris
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)

Secondary Outcome Measures

description of brain by MRI
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.
Evaluation of inflammation grade
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
measure the myostatin rate
To explore the role of Myostatin in the regulation loop of muscle function during frailty
measure the cystatin-C and creatinine rate
Determine 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 rate
Determine the associations between muscle alterations seen on MRI and serum IL-1b and IL-18.

Full Information

First Posted
August 19, 2019
Last Updated
October 19, 2021
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT04238494
Brief Title
Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrome; CLINical Study
Acronym
MIDAS
Official Title
Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrome; CLINical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 18, 2019 (Actual)
Primary Completion Date
May 30, 2022 (Anticipated)
Study Completion Date
May 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frail Elderly Syndrome, Diabetes
Keywords
imaging, myosteatosis (Myosteatosis is the pathologic accumulation of lipid that can occur in conjunction with atrophy and fibrosis following skeletal muscle injury)

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicomponent assessment: clinical, biological, functional, cognitive and MRI (muscle and brain)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Frail/prefrail
Arm Type
Experimental
Arm Description
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
Arm Title
non frail
Arm Type
Other
Arm Description
No Fried's criteria
Intervention Type
Diagnostic Test
Intervention Name(s)
Nuclear magnetic resonance (NMR)
Intervention Description
Muscle architecture, lipid and active tissue muscle content should be measured. Proton NMR imaging (MRI)
Primary Outcome Measure Information:
Title
Fat involution and trophicity in rectus femoris
Description
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)
Time Frame
day 1
Secondary Outcome Measure Information:
Title
description of brain by MRI
Description
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.
Time Frame
day 1
Title
Evaluation of inflammation grade
Description
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
Time Frame
day 1
Title
measure the myostatin rate
Description
To explore the role of Myostatin in the regulation loop of muscle function during frailty
Time Frame
day 1
Title
measure the cystatin-C and creatinine rate
Description
Determine the associations between muscle alterations seen on MRI and glomerular filtration rate estimated using serum cystatin-C or creatinine
Time Frame
day 1
Title
measure the serum interleukin IL-1b and IL-18 rate
Description
Determine the associations between muscle alterations seen on MRI and serum IL-1b and IL-18.
Time Frame
day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle BOURDEL-MARCHASSON, MD,PhD
Phone
+33 (0)5 57 65 65 71
Email
isabelle.bourdel-marchasson@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Fara RATSIMBAZAFY
Phone
+33(0)5 57 65 65 71
Email
fara.ratsimbazafy@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle BOURDEL-MARCHASSON, MD, PhD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de Médecine Gériatrique, CHU de LIMOGES
City
Limoges
ZIP/Postal Code
87000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Achille THCALLA, MD,PhD
Phone
+335 55 05 55 55
Email
achille.tchalla@unilim.fr
First Name & Middle Initial & Last Name & Degree
Caroline GAYOT
Phone
+335 55 05 69 57
Email
Caroline.Gayot@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
Achilla THCALLA, MD,PhD
Facility Name
Service de gériatrie - CHU Bordeaux - hôpital Xavier Arnozan
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Bourdel-Marchasson, MD, PhD
Phone
05 57 65 65 71
Email
isabelle.bourdel-marchasson@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Fara RATSIMBAZAFY
Phone
05 57 65 65 71
Email
fara.ratsimbazafy@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Isabelle Bourdel-Marchasson, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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