Exploring the impact of obesity on pediatric multiple sclerosis
Obesity as a Driver of Inflammation and Brain Volume Loss in Pediatric Multiple Sclerosis.
This study looks at how being overweight might affect the severity of multiple sclerosis in kids and teens aged 10 to 20.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 116 (estimated) |
| Ages | 10 Years to 20 Years |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Locations | 2 sites (Philadelphia, Pennsylvania and 1 other locations) |
| Trial ID | NCT04593082 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between obesity and the severity of multiple sclerosis (MS) in pediatric patients. It aims to evaluate how obesity-derived inflammatory mediators and imaging metrics correlate with MS progression in children aged 10 to 20 years. By understanding the role of childhood obesity in MS, the study seeks to provide insights into the disease's pathobiology and potential early intervention strategies.
Who should consider this trial
Good fit: Ideal candidates include pediatric patients aged 10 to 20 years with a diagnosis of relapsing-remitting multiple sclerosis within the last 36 months.
Not a fit: Patients with progressive forms of MS or other chronic immune diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to effective strategies for halting the progression of multiple sclerosis in children.
How similar studies have performed: While the relationship between obesity and adult MS has been explored, this specific focus on pediatric MS and obesity is relatively novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Pediatric MS subjects will meet below inclusion and exclusion criteria: Inclusion Criteria: * Ability to provide informed consent (or assent for minors) * Relapsing-remitting MS diagnosis per 2017 McDonald criteria * Ages ≥ 10 years to ≤ 20 years * Diagnosis of MS or first clinical symptom of MS (whichever comes first) within ≤ 36 months from the time of enrollment. Exclusion Criteria: * Progressive form of MS * Patients with an active, chronic disease of the immune system other than MS * Conditions affecting the central nervous system (CNS) white matter (e.g. leukodystrophy) or for whom another condition may better explain imaging abnormalities (e.g. lupus) * Myelin oligodendrocyte glycoprotein (MOG) antibodies on serologic testing * Corticosteroid exposure within 30 days of study enrollment Control subjects (Aim 2) will meet the below inclusion and exclusion criteria: Inclusion Criteria: * Ability to provide informed consent (or assent for minors) * Age-, sex-, \& BMI-matched to pediatric MS subjects (1:1 allocation) * Healthy children and young adults from the local communities Exclusion Criteria: * History of past imaging or neurologic event raising concern for any inflammatory CNS process * Medical history or previous/current diagnosis consistent with an autoimmune disorder pertaining to any system of the body (e.g. diabetes mellitus type 1, Crohn's disease, lupus)
Where this trial is running
Philadelphia, Pennsylvania and 1 other locations
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Virginia — Charlottesville, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: J Nicholas Brenton, MD — University of Virginia
- Study coordinator: J Nicholas Brenton, MD
- Email: jnb8h@virginia.edu
- Phone: 434-982-3936
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.