Obesity and Pediatric Multiple Sclerosis

April 27, 2026 updated by: J. Nicholas Brenton, MD, University of Virginia

Obesity as a Driver of Inflammation and Brain Volume Loss in Pediatric Multiple Sclerosis.

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

116

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • Virginia
      • Charlottesville, Virginia, United States, 22903
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population will be draw from outpatient clinics at UVA and CHOP as well as the surrounding communities for each institution. Subjects will be screened for eligibility to include BMI measurements at time of study discussion if they are interested.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Pediatric MS Subjects
Subjects with pediatric MS will undergo fasting lab work, non-contrasted MRI, DEXA scan, and surveys.
Healthy controls
Non-MS pediatric control subjects who will undergo fasting lab work, DEXA scan, and surveys for comparison to control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole brain volumes and focal demyelinating lesion volumes
Time Frame: 3 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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adipo-cytokine profiles
Time Frame: 3 years
Fasting adipo-cytokines from MS cohort will be compared to age-, sex-, and BMI-matched controls.
3 years
Adipo-cytokines correlation with brain volume loss and neuroaxonal injury
Time Frame: 3 years
We will measure serum NfL in MS subjects and controls. We will determine if leptin (a pro-inflammatory adipo-cytokine) predicts degree of brain volume loss and/or neuroaxonal injury in subjects with MS. This exploratory, mechanistic aim has potential to provide the first link between obesity-derived inflammation and neuronal cell injury/loss.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Virginia

Collaborators

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: J Nicholas Brenton, MD, University of Virginia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2021

Primary Completion (Estimated)

May 21, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

October 16, 2020

First Submitted That Met QC Criteria

October 16, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSR200257

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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