Frail Elderly SyndromeMIDASNCT04238494
Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrome; CLINical Study
A study testing Nuclear magnetic resonance (NMR) in people with Frail Elderly Syndrome and Diabetes, run by University Hospital, Bordeaux at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 70 to 90 years
- Conditions the study is for
- Frail Elderly Syndrome, Diabetes
- What is being tested?
- Nuclear magnetic resonance (NMR)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- 18 Oct 2019to 30 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Isabelle BOURDEL-MARCHASSON, MD,PhD contact
France2 sites, 2 recruiting
- Not yet recruiting
Service de Médecine Gériatrique, CHU de LIMOGES
Limoges, 87000
Achille THCALLA, MD,PhD, +335 55 05 55 55, achille.tchalla@unilim.fr
Caroline GAYOT, +335 55 05 69 57, Caroline.Gayot@chu-limoges.fr
- Recruiting
Service de gériatrie - CHU Bordeaux - hôpital Xavier Arnozan
Pessac, 33604
Isabelle Bourdel-Marchasson, MD, PhD, 05 57 65 65 71, isabelle.bourdel-marchasson@chu-bordeaux.fr
Fara RATSIMBAZAFY, 05 57 65 65 71, fara.ratsimbazafy@chu-bordeaux.fr
About this study
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.
Read the 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.
- Conditions
- Frail Elderly Syndrome, Diabetes
- Being tested
- Nuclear magnetic resonance (NMR)
- Keywords
- imaging, myosteatosis (Myosteatosis is the pathologic accumulation of lipid that can occur in conjunction with atrophy and fibrosis following skeletal muscle injury)
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nuclear magnetic resonance (NMR)Diagnostic test
Muscle architecture, lipid and active tissue muscle content should be measured. Proton NMR imaging (MRI)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Nuclear magnetic resonance (NMR) |
| non frail | Other | No Fried's criteria Receives: Diagnostic Test: Nuclear magnetic resonance (NMR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: day 1
Secondary outcomes (5)
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.
Measured: day 1
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
Measured: day 1
measure the myostatin rate
To explore the role of Myostatin in the regulation loop of muscle function during frailty
Measured: day 1
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
Measured: day 1
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.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start18 Oct 2019
- Primary completion30 May 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Multicomponent assessment: clinical, biological, functional, cognitive and MRI (muscle and brain)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle BOURDEL-MARCHASSON, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238494
- Sponsor's protocol ID
- CHUBX 2019/09
- Acronym
- MIDAS
- Status last verified
- Oct 2021
- First submitted
- 19 Aug 2019
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrome; CLINical Study
- ClinicalTrials.gov ID
- NCT04238494
- Acronym / sponsor ID
- MIDAS / CHUBX 2019/09
- 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)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicomponent assessment: clinical, biological, functional, cognitive and MRI (muscle and brain)
| Arm | Type | Receives |
|---|---|---|
| Frail/prefrail | Experimental | Diagnostic Test: Nuclear magnetic resonance (NMR)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 |
| non frail | Other | Diagnostic Test: Nuclear magnetic resonance (NMR)No Fried's criteria |
Who may qualify
- Ages
- 70 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nuclear magnetic resonance (NMR)Muscle architecture, lipid and active tissue muscle content should be measured. Proton NMR imaging (MRI) | Diagnostic test | Frail/prefrail, non frail |
Primary outcome
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)
5 secondary outcomes
description of brain by MRI
Time frame: day 1
Evaluation of inflammation grade
Time frame: day 1
measure the myostatin rate
Time frame: day 1
measure the cystatin-C and creatinine rate
Time frame: day 1
measure the serum interleukin IL-1b and IL-18 rate
Time frame: day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle BOURDEL-MARCHASSON, MD,PhD contact
Isabelle BOURDEL-MARCHASSON, MD, PhD principal investigator
University Hospital, Bordeaux
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nuclear magnetic resonance (NMR) in people with Frail Elderly Syndrome and Diabetes, run by University Hospital, Bordeaux at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabelle BOURDEL-MARCHASSON, MD,PhD (+33 (0)5 57 65 65 71, isabelle.bourdel-marchasson@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat involution and trophicity in rectus femoris (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.