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Obesity and Pediatric Multiple Sclerosis
NCT04593082 · University of Virginia
In plain English
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Official title
Obesity as a Driver of Inflammation and Brain Volume Loss in Pediatric Multiple Sclerosis.
About this study
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 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)
Study design
Enrollment target: 116 participants
Age groups: child, adult
Timeline
Starts: 2021-06-03
Estimated completion: 2025-06-01
Last updated: 2024-12-09
Primary outcomes
- • Whole brain volumes and focal demyelinating lesion volumes (3 years)
Sponsor
University of Virginia · other
With: Children's Hospital of Philadelphia
Contacts & investigators
ContactJ Nicholas Brenton, MD · contact · jnb8h@virginia.edu · 434-982-3936
ContactMargaret Keller · contact · mfk8e@hscmail.mcc.virginia.edu · 434-297-4102
InvestigatorJ Nicholas Brenton, MD · principal_investigator, University of Virginia
All locations (2)
Children's Hospital of PhiladelphiaRecruiting
Philadelphia, Pennsylvania, United States
University of VirginiaRecruiting
Charlottesville, Virginia, United States