Clinical trial NCT04593082: Obesity and Pediatric Multiple Sclerosis
Official title: Obesity as a Driver of Inflammation and Brain Volume Loss in Pediatric Multiple Sclerosis.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Keywords: Pediatric
Obesity
Neurodegeneration
Inflammation
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2020-10-19
Enrollment: 116
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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.

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)

Primary outcomes:
measure: Whole brain volumes and focal demyelinating lesion volumes
timeFrame: 3 years
Secondary outcomes:
measure: Adipo-cytokine profiles
timeFrame: 3 years
measure: Adipo-cytokines correlation with brain volume loss and neuroaxonal injury
timeFrame: 3 years
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: J Nicholas Brenton, MD
role: PRINCIPAL_INVESTIGATOR
References:
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