Obesity and Pediatric Multiple Sclerosis
Purpose
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.
Condition
- Multiple Sclerosis
Eligibility
- Eligible Ages
- Between 10 Years and 20 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- Study Type
- Observational
- Observational Model
- Case-Control
- Time Perspective
- Cross-Sectional
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
Recruiting Locations
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Contact:
Micky Bacchus
Micky Bacchus
University of Virginia
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
More Details
- NCT ID
- NCT04593082
- Status
- Recruiting
- Sponsor
- University of Virginia