NCT04593082Active, not recruiting
Obesity and Pediatric Multiple Sclerosis
Obesity as a Driver of Inflammation and Brain Volume Loss in Pediatric Multiple Sclerosis.
Source: ClinicalTrials.gov · Last updated 29 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 116 (estimated)
- First submitted
- 16 Oct 2020
- Start date
- 3 Jun 2021
- Primary completion date
- 21 May 2026
- Lead sponsor
- University of Virginia
- Diseases
- Obesity, Multiple sclerosis
- NCT number
- NCT04593082
What you commit to
- Study type: Observational
- Planned participants: 116
- From 3 Jun 2021 to the primary completion date, 21 May 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
- 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)
Other illness
- 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)
- History of past imaging or neurologic event raising concern for any inflammatory CNS process
Other
- Progressive form of MS
Who the study is looking for
- 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.
- 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
Criteria the registry did not label
- Pediatric MS subjects will meet below inclusion and exclusion criteria:
Age in the registry: 10 years to 20 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.