Obesity as a Driver of Inflammation and Brain Volume Loss in Pediatric Multiple Sclerosis.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 116
- 试验地点
- 4
- 主要终点
- Whole brain volumes and focal demyelinating lesion volumes
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 10 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric MS subjects will meet below inclusion and
排除标准
- •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)
研究组 & 干预措施
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.
结局指标
主要结局
Whole brain volumes and focal demyelinating lesion volumes
时间窗: 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.
次要结局
- Adipo-cytokines correlation with brain volume loss and neuroaxonal injury(3 years)
- Adipo-cytokine profiles(3 years)
研究者
J. Nicholas Brenton, MD
Assistant Professor of Neurology and Pediatrics
University of Virginia