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

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ClinicalTrials.gov Identifier: NCT04238494
Recruitment Status : Recruiting
First Posted : January 23, 2020
Last Update Posted : January 23, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.


Condition or disease Intervention/treatment Phase
Frail Elderly Syndrome Diabetes Diagnostic Test: Nuclear magnetic resonance (NMR) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicomponent assessment: clinical, biological, functional, cognitive and MRI (muscle and brain)
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrome; CLINical Study
Actual Study Start Date : October 18, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : March 30, 2021

Resource links provided by the National Library of Medicine


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
Diagnostic Test: Nuclear magnetic resonance (NMR)
Muscle architecture, lipid and active tissue muscle content should be measured. Proton NMR imaging (MRI)

non frail
No Fried's criteria
Diagnostic Test: Nuclear magnetic resonance (NMR)
Muscle architecture, lipid and active tissue muscle content should be measured. Proton NMR imaging (MRI)




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. measure the myostatin rate [ Time Frame: day 1 ]
    To explore the role of Myostatin in the regulation loop of muscle function during frailty

  4. 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

  5. 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.



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Ages Eligible for Study:   70 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04238494


Contacts
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Contact: Isabelle BOURDEL-MARCHASSON, MD,PhD +33 (0)5 57 65 65 71 isabelle.bourdel-marchasson@chu-bordeaux.fr
Contact: Fara RATSIMBAZAFY +33(0)5 57 65 65 71 fara.ratsimbazafy@chu-bordeaux.fr

Locations
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France
Service de Médecine Gériatrique, CHU de LIMOGES Not yet recruiting
Limoges, France, 87000
Contact: Achille THCALLA, MD,PhD    +335 55 05 55 55    achille.tchalla@unilim.fr   
Contact: Caroline GAYOT    +335 55 05 69 57    Caroline.Gayot@chu-limoges.fr   
Principal Investigator: Achilla THCALLA, MD,PhD         
Service de gériatrie - CHU Bordeaux - hôpital Xavier Arnozan Recruiting
Pessac, France, 33604
Contact: Isabelle Bourdel-Marchasson, MD, PhD    05 57 65 65 71    isabelle.bourdel-marchasson@chu-bordeaux.fr   
Contact: Fara RATSIMBAZAFY    05 57 65 65 71    fara.ratsimbazafy@chu-bordeaux.fr   
Principal Investigator: Isabelle Bourdel-Marchasson, MD,PhD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Isabelle BOURDEL-MARCHASSON, MD, PhD University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04238494    
Other Study ID Numbers: CHUBX 2019/09
First Posted: January 23, 2020    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
imaging
myosteatosis (Myosteatosis is the pathologic accumulation of lipid that can occur in conjunction with atrophy and fibrosis following skeletal muscle injury)
Additional relevant MeSH terms:
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Sarcopenia
Syndrome
Frailty
Disease
Pathologic Processes
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms