Impaired Glucose Tolerance and Cognition in MS
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Assessment of glucose intolerance on clinical outcome measure of disability.
研究概览
简要总结
This is a pilot study to compare cognitive performance in two groups of subjects with multiple sclerosis; those with normal glucose tolerance and those with impaired glucose tolerance. The study consists of a 2 hour oral glucose tolerance test, patient reported outcomes, a series of cognitive functioning tests, and outpatient physical assessment using a pedometer.
详细描述
Investigators plan to recruit 100 compliant patients with relapsing-remitting MS who are willing to come fasting for an oral glucose tolerance test to determine the relationship between glucose tolerance and cognition in MS patients.
Eligible study subjects expressing interest will be given a copy of the consent to review and will have the opportunity to ask questions. If the subject passes screening, they will be invited for their research visit. Signed consent form at the visit will be obtained before any study related procedures take place.
Baseline Measurements: Measurements for all subjects will include age, race/ethnicity, sex, weight, height, waist circumference, blood pressure. Relevant medical history, current medications, and family history diabetes will be reviewed and documented by both subject report and medical records. If the subject is a woman of child-bearing ability, urine pregnancy test will be done in order to exclude pregnant subjects. All subjects will then have an IV placed and have blood drawn to measure their fasting blood glucose level. Fasting blood glucose above 126 ug/dl would be a screen failure for this study.
Labs: The following labs will be drawn for all subjects.
- Blood glucose management (hemoglobin A1C, insulin-like growth factor, insulin) - these tests show how your body manages sugar
- Lipids & Metabolic Markers (fasting lipid profile, leptin, adiponectin) - these measure signal proteins in your blood for metabolism
- Cytokine profile - to assess impact of blood sugar and inflammatory factors (molecules that may indicate how well your immune system works) on recovery from your MS relapse
- Sodium level - to assess how your body uses water
- Vitamin D25 - measures amount of vitamin D in your body
- Neuro-filament light measurement - marker of neurodegeneration
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to provide informed consent
- •Diagnosis of Clinically Isolated Syndrome (CIS) or Relapsing Remitting Multiple Sclerosis (RRMS) confirmed by McDonald 2010 criteria
- •EDSS < 6.5 at time of visit
排除标准
- •Diabetes type I or II
- •use of glucose regulating medications
- •fasting blood glucose of > 126 mg/dl
- •known cardiac or respiratory disease
- •morbid obesity (BMI >40)
- •steroid exposure within 4 weeks of enrollment
- •pregnancy or current use of hormone replacement therapy
结局指标
主要结局
Assessment of glucose intolerance on clinical outcome measure of disability.
时间窗: 1 year
The expanded disability scale (EDSS) will be used to determine a subjects level of disability. This value will then be compared to the subjects category of glucose intolerance, measured by yes (abnormal glucose tolerance) or no (normal glucose tolerance). This is on a score from 0 (no disability) to 8 (bedridden)
次要结局
未报告次要终点
研究者
J. Nicholas Brenton, MD
Principal Investigator
University of Virginia