Obesity and Pediatric Multiple Sclerosis

Running, not enrolling

Conditions studied: Multiple Sclerosis

In brief

Obesity is one possible contributor to severity of multiple sclerosis and progression of the disease. We already know that obesity is a risk determinant for acquiring MS, yet the impact of obesity on pediatric MS disease expression and course is unknown. This study will evaluate the relationship between obesity, obesity-derived inflammatory mediators, and imaging metrics of MS severity in children. Understanding how childhood obesity contributes to MS severity/progression may yield fundamental insights into disease pathobiology - which may thereby lead to effective strategies for halting its progression in its earliest stages.

Key facts

Study ID

NCT04593082

Run by

University of Virginia

People needed

116

Starts

2021-06-03

Expected to finish

2027-06-01

Last updated by the study team

2026-04-29

Who can join

Age: 10 and older, up to 20. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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