Clinical trial

Obesity and Pediatric Multiple Sclerosis

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT04593082

Active, not recruitingNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age10 Years to 20 Years

SexAll

Healthy volunteersAccepted

ConditionMultiple Sclerosis

Full registry 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)

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Whole brain volumes and focal demyelinating lesion volumes3 years

58 patients with a recent MS diagnosis, stratified by weight category (29 normal weight and 29 overweight/obese). Subjects will undergo MRI to quantify total brain and lesion volume. Z-scores for volumetrics will be determined using age- and sex-matched normative data from the NIH-sponsored ABCD dataset. We will compare mean Z-scores of whole brain volume and focal demyelinating lesion volumes between the two groups.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

University of Virginia🇺🇸 Charlottesville, Virginia, United States

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Children's Hospital of Philadelphia🇺🇸 Philadelphia, Pennsylvania, United States

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