Obesity and 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Body Weight Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Inflammation Nerve Degeneration Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

10 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

Adipo-cytokine profiles

Time frame: 3 years

Fasting adipo-cytokines from MS cohort will be compared to age-, sex-, and BMI-matched controls.
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.

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

Children's Hospital of Philadelphia

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2026
Study completion: 2027
First posted: Oct 19, 2020
Registry last updated: Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Active, Not Recruiting