Obesity and Pediatric Multiple Sclerosis

NCT04593082 | Active Not Recruiting

• 1 other identifier: HSR200257
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 2

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.

Conditions

Multiple Sclerosis

Keywords

Pediatric; Obesity; Neurodegeneration; Inflammation

Outcome Measures

Primary Outcomes (1)

• Whole brain volumes and focal demyelinating lesion volumes

  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 Outcomes (2)

• Adipo-cytokine profiles

  3 years

• Adipo-cytokines correlation with brain volume loss and neuroaxonal injury

  3 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may not qualify if:

• 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.
• 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
• 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
• 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)

Sponsors & Collaborators

• University of Virginia: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (2)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (20)

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• Woolbright EB, Brenton JN. Attitudes toward obestity and diet modification in pediatric MS patients. Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS); February, 28 2020, 2019; West Palm Beach, FL.

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  PMID: 29542376 BACKGROUND

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  BACKGROUND

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MeSH Terms

Conditions

Multiple Sclerosis; Obesity; Nerve Degeneration; Inflammation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Officials

• J Nicholas Brenton, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology and Pediatrics

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 19, 2020
• Study Start: June 3, 2021
• Primary Completion: May 21, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (2)