Obesity and Pediatric Multiple Sclerosis
NCT04593082
Summary
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.
Eligibility
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)
Conditions2
Locations2 sites
Pennsylvania
1 siteVirginia
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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NCT04593082