Obesity and Pediatric Multiple Sclerosis (NCT04593082) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Obesity and Pediatric Multiple Sclerosis
United States116 participantsStarted 2021-06-03
Plain-language 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.
Who can participate
Age range
10 Years – 20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Whole brain volumes and focal demyelinating lesion volumes