Insulin Resistance in Multiple System Atrophy

NCT04250493 | Recruiting

• 1 other identifier: CHUBX 2018/30
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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

Multiple System Atrophy

Keywords

Multiple system atrophy; Neurodegenerative disease; Alpha synuclein; Insulin resistance

Outcome Measures

Primary Outcomes (1)

• HOMA Index

  Homeostasis Model Assessment of insulin resistance (HOMA) index, calculated from a fasted blood glucose and insulin level between AMS patients and a formula-controlled group (insulinemia x glycemia)/22.5 insulinemia being expressed in mU/l and glucose in mmol/L.

  Day 0

Secondary Outcomes (11)

• IRS-1pS312 (Insulin Receptor Substrate-1, Phosphorylated at Serine 312) concentration

  Day 0

• Unified Multiple System Atrophy Rating Scale (UMSARS) score

  Day 0

• Unified Multiple System Atrophy Rating Scale (UMSARS) score

  One year

• COMPosite Autonomic Symptoms Score (COMPASS-31)

  Day 0

• COMPosite Autonomic Symptoms Score (COMPASS-31)

  One year

Study Arms (2)

MSA patient

EXPERIMENTAL

Patients will be recruited at the French Reference Center for MSA.

Biological: Homeostasis Model Assessment of insulin resistance (HOMA); Behavioral: MOntreal Cognitive Assessment (MoCA); Behavioral: Clinical characteristics of AMS patients; Procedure: Brain Magnetic Resonance Imaging (MRI); Biological: Blood sampling

Control

OTHER

Healthy volunteer matched for age (+/- 5years) and sex with MSA patient.

Biological: Homeostasis Model Assessment of insulin resistance (HOMA); Behavioral: MOntreal Cognitive Assessment (MoCA); Procedure: Brain Magnetic Resonance Imaging (MRI); Biological: Blood sampling

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

Control; MSA patient

MOntreal Cognitive Assessment (MoCA) BEHAVIORAL

Cognitive evaluation with MOntreal Cognitive Assessment (MoCA)

Control; MSA patient

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)

MSA patient

Brain Magnetic Resonance Imaging (MRI) PROCEDURE

Brain Magnetic Resonance Imaging (MRI) : putamen imaging, bridge and cerebellum; white substance hypersignals volume

Control; MSA patient

Blood sampling BIOLOGICAL

Optional blood sampling for the constitution of a biological collection

Control; MSA patient

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients :
• Patients suffering from "possible" or "probable" MSA according to clinical consensus criteria (Gilman et al., 2008).
• Age \> 30
• Written informed consent
• Patient covered by the national health system
• Controls:
• Patients not suffering from a neurologic disorder
• Age \> 30
• Written informed consent
• Patient covered by the national health system

You may not qualify if:

• For patients and controls:
• Presence of a diabetes
• Treatment with corticosteroids, estrogen, atypical antipsychotics, and anti-retroviral agents
• Patient under tutelage
• Patient unable to give consent
• Any other neurologic disorder
• Pregnancy and breastfeeding
• MOCA ≤21
• Contraindication to perform an MRI

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• University of Bordeaux: collaborator
• Labex Brain: collaborator
• Centre National de la Recherche Scientifique, France: collaborator

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33 076, France

RECRUITING

MeSH Terms

Conditions

Multiple System Atrophy; Neurodegenerative Diseases; Parkinson Disease 4, Autosomal Dominant Lewy Body; Insulin Resistance

Interventions

Mental Status and Dementia Tests; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Wassilios MEISSNER

CONTACT

05 57 82 14 20; wassilios.meissner@chu-bordeaux.fr

Study Design

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

Study Record Dates

• First Submitted: January 29, 2020
• First Posted: January 31, 2020
• Study Start: October 28, 2020
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): October 28, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

FR (1)