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

Diabetes Clinical Trial

— MIDAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04238494
• Other study ID #: CHUBX 2019/09
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2019
• Est. completion date: May 30, 2022

Study information

• Verified date: October 2021
• Source: University Hospital, Bordeaux
• Contact: Isabelle BOURDEL-MARCHASSON, MD,PhD
• Phone: +33 (0)5 57 65 65 71
• Email: isabelle.bourdel-marchasson[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes
• Frail Elderly Syndrome
• Frailty
• Sarcopenia
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Service de Médecine Gériatrique, CHU de LIMOGES	Limoges
France	Service de gériatrie - CHU Bordeaux - hôpital Xavier Arnozan	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	day 1
Secondary	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.	day 1
Secondary	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	day 1
Secondary	measure the myostatin rate	To explore the role of Myostatin in the regulation loop of muscle function during frailty	day 1
Secondary	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	day 1
Secondary	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.	day 1