Obesity and Pediatric Multiple Sclerosis

University of Virginia

Status

Enrolling

Conditions

Multiple Sclerosis

Study type

Observational

Funder types

Other

Identifiers

NCT04593082

HSR200257

Details and patient eligibility

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.

Enrollment

116 estimated patients

Sex

All

Ages

10 to 20 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and 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)