Obesity and Pediatric Multiple Sclerosis

Recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT04593082
• Lead Sponsor: University of Virginia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-10-16
• Study First Posted: 2020-10-19
• Study Start: 2021-06-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-09
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Whole brain volumes and focal demyelinating lesion volumes	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 Outcome Measures

Name	Time	Method
Adipo-cytokines correlation with brain volume loss and neuroaxonal injury	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.
Adipo-cytokine profiles	3 years	Fasting adipo-cytokines from MS cohort will be compared to age-, sex-, and BMI-matched controls.

Trial Locations

Locations (2)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States