Obesity and Pediatric Multiple Sclerosis

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04593082

Enrollment

116

Registered

2020-10-19

Start date

2021-06-03

Completion date

2027-06-01

Last updated

2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Pediatric, Obesity, Neurodegeneration, Inflammation

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

10 Years to 20 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Adipo-cytokine profiles	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	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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJ Nicholas Brenton, MD

University of Virginia

Outcome results