Insulin Resistance in Multiple System Atrophy

Sponsor
University Hospital, Bordeaux
Study ID
NCT04250493
Status
Recruiting
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Conditions

  • Multiple System Atrophy

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Homeostasis Model Assessment of insulin resistance (HOMA) — BIOLOGICAL
    Fasting blood sample for : glucose, insulinemia, hemoglobin and lipid test to determine the Homeostasis Model Assessment of insulin resistance (HOMA) index
  • MOntreal Cognitive Assessment (MoCA) — BEHAVIORAL
    Cognitive evaluation with MOntreal Cognitive Assessment (MoCA)
  • Clinical characteristics of AMS patients — BEHAVIORAL
    Severity and progression of motor disorders assessed by the UMSARS scale, severity of dysautonomia assessed by the COMPASS31 scale ; quality of life questionnaire (AMS-Qol) for the level of difficulty experienced by the patient (on activities such as : move; walk; maintain balance; talk; feed)
  • Brain Magnetic Resonance Imaging (MRI) — PROCEDURE
    Brain Magnetic Resonance Imaging (MRI) : putamen imaging, bridge and cerebellum; white substance hypersignals volume
  • Blood sampling — BIOLOGICAL
    Optional blood sampling for the constitution of a biological collection

Study Details

Multiple system atrophy (MSA) is a rare and fatal neurodegenerative disorder. The pathologic hallmark is the accumulation of aggregated alpha-synuclein in oligodendrocytes forming glial cytoplasmic inclusions. Some symptomatic treatments are available while disease-modification remains an unmet treatment need. Post-mortem findings suggest insulin resistance, i.e. reduced insulin signaling, in the brains of MSA patients. The aim of this study is to complete the target validation of insulin resistance for future treatment trials.

Key Dates

First listed
Jan 31, 2020
Start date
Oct 28, 2020
Status verified
Jul 2025
Primary completion
Oct 28, 2026
Completion
Oct 28, 2027

Study Design

Enrollment
124 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: MSA patient
    Patients will be recruited at the French Reference Center for MSA.
  • Other: Control
    Healthy volunteer matched for age (+/- 5years) and sex with MSA patient.

Primary Outcome Measure

HOMA Index [ Time Frame: Day 0 ]

Central Contacts

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