ClinicalTrials.gov record NCT04250493
Insulin Resistance in Multiple System Atrophy
Insulin Resistance in Multiple System Atrophy
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This study compares measures of insulin resistance in people with Multiple System Atrophy (MSA) and matched healthy controls. Participants have fasting blood tests to calculate HOMA, plasma exosome testing for IRS-1pS312, brain MRI, cognitive testing, and clinical scales; some measures are repeated at one year. The goal is to validate insulin resistance as a target for future treatment trials.
What it is studying. Whether peripheral and neuronal markers of insulin resistance can be measured and characterized in people with MSA compared with matched healthy controls—specifically fasting HOMA index and neuronal IRS-1pS312 in plasma exosomes—alongside clinical and MRI measures.
What the researchers hope to learn. To further characterize peripheral and central insulin resistance in MSA; to measure HOMA and neuronal IRS-1pS312 levels and their relationship to clinical scales and MRI; to validate insulin resistance as a target for future treatment trials.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Biological
- Homeostasis Model Assessment of insulin resistance (HOMA)
- Blood sampling
- Procedure
- Brain Magnetic Resonance Imaging (MRI)
- Behavioral
- MOntreal Cognitive Assessment (MoCA)
- Clinical characteristics of AMS patients
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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
Exclusion criteria
- 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
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
Multiple system atrophy (MSA) patients have a poor prognosis with a median survival ranging between 6 and 10 years. MSA belongs to the synucleinopathies, which are characterized by the abnormal accumulation of alpha-synuclein. We have recently shown brain insulin resistance (i.e. reduced insulin signaling) in post-mortem brain tissue of MSA patients and transgenic MSA mice, as illustrated by increased protein levels of insulin receptor substrate-1 phosphorylated at serine 312 (IRS-1pS312). Additionally, exendin-4, an approved anti-diabetic drug targeting glucagon-like peptide-1 (GLP-1) receptors, was capable of decreasing brain levels of IRS-1pS312 and preserving dopamine neurons in transgenic MSA mice. We further observed an inverse correlation between plasma neural-derived exosomal IRS-1pS312 levels and survival of dopamine neurons in transgenic MSA mice. The aim of this study is to further characterize peripheral and central insulin resistance in MSA patients, thereby validating this target for future treatment trials. For this purpose, fasting blood glucose and insulin levels will be determined in samples of MSA patients and healthy controls for a homeostatic model assessment of insulin resistance (HOMA). Additionally, IRS-1pS312 will be measured in neural-derived plasma exosomes of MSA patients and healthy controls.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
At a baseline visit participants will fast and give blood for glucose, insulin, hemoglobin and lipids to calculate HOMA and for plasma neuronal‑exosome testing (IRS‑1pS312). Participants will complete the MOntreal Cognitive Assessment (MoCA); MSA patients will also complete clinical scales and questionnaires (UMSARS, COMPASS‑31, AMS‑Qol). A brain MRI is performed to measure brain region volumes and white‑matter changes. Many assessments (clinical scales, MoCA and MRI) are repeated at one year; additional optional blood may be taken for a biological collection.
How the study is structured. Interventional, non-randomized, parallel assignment with two groups (MSA patients and matched healthy controls). No masking. Participants undergo baseline (Day 0) testing including fasting blood draws, plasma exosome analysis, brain MRI, cognitive assessment (MoCA), and clinical scales; several outcomes are reassessed at one year.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on multiple system atrophy
Important dates
- Study start
- Oct 28, 2020
- Primary completion
- Oct 28, 2026 (estimated)
- Study completion
- Oct 28, 2027 (estimated)
- Target enrollment
- 124 participants (estimated)
- Last updated on registry
- Jul 20, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- University Hospital, Bordeaux
- Collaborators
- University of Bordeaux
- Labex Brain
- Centre National de la Recherche Scientifique, France
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Wassilios MEISSNER 📞 05 57 82 14 20 ✉ wassilios.meissner@chu-bordeaux.fr
Participating sites (1)
- CHU de BordeauxRecruiting
Bordeaux, 33 076 · France
- Wassilios MEISSNER · 05 57 82 14 20 · wassilios.meissner@chu-bordeaux.fr
Terms used on this page · explanations by MedicalUpdates.ai
- Written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- corticosteroids
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- Contraindication
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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