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Obesity and Pediatric Multiple Sclerosis
Obesity and Pediatric Multiple Sclerosis

NCT04593082

Active Not RecruitingN/A

Sponsor: University of Virginia

Conditions: Multiple Sclerosis

Countries: United States

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 overview

Sex: ALL

Age: 10 Years to 20 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility 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)
Locations (2)
  • Philadelphia, Pennsylvania, United States
  • Charlottesville, Virginia, United States