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

NCT04238494 | Unknown

• 1 other identifier: CHUBX 2019/09
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• description of brain by MRI

  day 1

• Evaluation of inflammation grade

  day 1

• measure the myostatin rate

  day 1

• measure the cystatin-C and creatinine rate

  day 1

• measure the serum interleukin IL-1b and IL-18 rate

  day 1

Study Arms (2)

Frail/prefrail

EXPERIMENTAL

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)

non frail

OTHER

No Fried's criteria

Diagnostic Test: Nuclear magnetic resonance (NMR)

Interventions

Nuclear magnetic resonance (NMR) DIAGNOSTIC_TEST

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

Frail/prefrail; non frail

Eligibility Criteria

• Age: 70 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (2)

Service de Médecine Gériatrique, CHU de LIMOGES

Limoges, 87000, France

NOT YET RECRUITING

Service de gériatrie - CHU Bordeaux - hôpital Xavier Arnozan

Pessac, 33604, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Isabelle BOURDEL-MARCHASSON, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle BOURDEL-MARCHASSON, MD,PhD

CONTACT

+33 (0)5 57 65 65 71; isabelle.bourdel-marchasson@chu-bordeaux.fr

Fara RATSIMBAZAFY

CONTACT

+33(0)5 57 65 65 71; fara.ratsimbazafy@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: January 23, 2020
• Study Start: October 18, 2019
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)