Insulin Resistance in Multiple System Atrophy
NCT04250493 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124
Last updated 2025-07-20
Summary
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.
Conditions
Interventions
- BIOLOGICAL
-
Homeostasis Model Assessment of insulin resistance (HOMA)
Fasting blood sample for : glucose, insulinemia, hemoglobin and lipid test to determine the Homeostasis Model Assessment of insulin resistance (HOMA) index
- BEHAVIORAL
-
MOntreal Cognitive Assessment (MoCA)
Cognitive evaluation with MOntreal Cognitive Assessment (MoCA)
- BEHAVIORAL
-
Clinical characteristics of AMS patients
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)
- PROCEDURE
-
Brain Magnetic Resonance Imaging (MRI)
Brain Magnetic Resonance Imaging (MRI) : putamen imaging, bridge and cerebellum; white substance hypersignals volume
- BIOLOGICAL
-
Blood sampling
Optional blood sampling for the constitution of a biological collection
Sponsors & Collaborators
-
University of Bordeaux
collaborator OTHER -
Labex Brain
collaborator OTHER -
Centre National de la Recherche Scientifique, France
collaborator OTHER -
University Hospital, Bordeaux
lead OTHER
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 30 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-10-28
- Primary Completion
- 2026-10-28
- Completion
- 2027-10-28
Countries
- France
Study Locations
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