Insulin Resistance in Multiple System Atrophy

NCT04250493 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2025-07-20

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04250493 on ClinicalTrials.gov