Obesity as a Driver of Inflammation and Brain Volume Loss in Pediatric Multiple Sclerosis.
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Virginia
- Enrollment
- 116
- Locations
- 4
- Primary Endpoint
- Whole brain volumes and focal demyelinating lesion volumes
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 10 Years to 20 Years (Child, Adult)
- Sex
- All
- Accepts 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.
- •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
Arms & Interventions
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.
Outcomes
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-cytokines correlation with brain volume loss and neuroaxonal injury(3 years)
- Adipo-cytokine profiles(3 years)
Investigators
J. Nicholas Brenton, MD
Assistant Professor of Neurology and Pediatrics
University of Virginia