Insulin resistance in multiple system atrophy
This project will test whether people with multiple system atrophy have signs of insulin resistance in fasting blood and neural-derived plasma exosomes compared with healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 30 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT04250493 on ClinicalTrials.gov |
What this trial studies
This observational interventional study compares fasting glucose/insulin HOMA measurements and levels of phosphorylated IRS-1 (IRS-1pS312) in neural-derived plasma exosomes between adults with possible or probable MSA and age-matched healthy controls. Participants will undergo fasting blood draws, MoCA cognitive testing, clinical characterization, and brain MRI, and samples will be analyzed for HOMA and IRS-1pS312. The aim is to validate peripheral biomarkers that reflect central insulin resistance previously observed in post-mortem MSA tissue and in transgenic MSA mice. Key exclusions include diabetes, certain medications, other neurologic disorders, significant cognitive impairment, and MRI contraindications.
Who should consider this trial
Good fit: Ideal participants are adults over 30 with possible or probable MSA who can give informed consent, are covered by the national health system, and do not have diabetes or excluded medications.
Not a fit: People with diabetes, other neurologic disorders, MoCA ≤21, pregnancy or breastfeeding, or those on excluded medications are unlikely to gain benefit from this biomarker validation study.
Why it matters
Potential benefit: If successful, validating insulin resistance as a target could enable trials of GLP-1–based or other insulin-sensitizing therapies for MSA.
How similar studies have performed: Preclinical work in transgenic MSA mice and post-mortem human brain studies showed brain insulin resistance and a protective effect of the GLP-1 agonist exendin-4 in mice, but prospective in vivo human validation is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bordeaux
- CHU de Bordeaux — Bordeaux, France (Recruiting)
Study contacts
- Study coordinator: Wassilios MEISSNER
- Email: wassilios.meissner@chu-bordeaux.fr
- Phone: 05 57 82 14 20
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.