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临床试验/NCT03004079
NCT03004079Unknown不适用

Assessment of the Clinical Importance of Insulin Resistance & Steroid-Associated Hyperglycemia in Relapsing Multiple Sclerosis

University of Virginia1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
试验地点
1
主要终点
Relapse Recovery & Hyperglycemia

研究概览

简要总结

The purpose of this study is to assess the relationship of blood glucose levels in persons with Multiple Sclerosis (MS) who have experienced a relapse and will be receiving intravenous steroids for the relapse, to their recovery from the relapse.

Steroid exposure commonly leads to elevated serum blood glucose, however, standardized monitoring of blood glucose levels in the outpatient setting is not common. The clinical impact of any associated elevated blood glucose during steroid administration is unknown. We hypothesize that the blood glucose response to steroid treatment is clinically relevant to the MS-relapse recovery.

详细描述

Multiple Sclerosis (MS) is a neuroinflammatory and degenerative central nervous system disorder. The majority of patients have an early relapsing-remitting course. Standard treatment for an MS-relapse is intravenous methylprednisolone (IVMP), typically 1000 mg daily for 3 days. Despite IVMP treatment, >40% of MS patients experience residual deficits after an MS-relapse. Potential risk factors for poor relapse recovery remain unclear.

Elevated serum blood glucose is a common and well-defined consequence of steroid administration, attributed to steroid-related reductions in insulin sensitivity. Individuals with pre-treatment insulin resistance (e.g. diabetics) will exhibit an amplified hyperglycemic response. Reduced mobility, sedentary lifestyle, and repeated exposure to steroids- all of which are common in MS - are recognized risk factors for insulin resistance. These factors may make MS patients particularly susceptible to steroid-induced hyperglycemia. While, MS patients commonly receive intravenous steroids, the clinical impact of any associated hyperglycemia is unknown.

Study Design and Methods Timeline: Study will require 3 visits over a 6 month period.

Subjects: MS subjects who are experiencing an acute relapse will be recruited for the study. Prior to any study procedures, the PI or research coordinator will obtain full written informed consent.

Baseline Measurements: age, race/ethnicity, sex, weight, height, waist circumference, blood pressure, previous steroid exposure (dates, frequency, steroid type and dose), smoking history, and family history of diabetes. Medication review will include MS disease-modifying therapy, symptomatic medications, and non-MS-related medications. Additional MS-related information will include dates of initial MS-symptom onset, MS diagnosis, and onset of presenting relapse symptoms.

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Ability to provide informed consent
  • Age 18 -59 years (inclusive)
  • Ability to walk continuously for 6 minutes (per patient report)
  • Clinically Isolated Syndrome (CIS) or Relapsing Remitting MS (RRMS) confirmed diagnosis by McDonald 2010 criteria
  • Current MS relapse with objective findings on exam
  • Relapse symptom onset within 2-weeks of screening
  • Functional System Scores obtainable from a clinic visit within 6 months of the relapse assessment visit
  • EDSS < 6.5 at time of screening visit
  • Inpatient, outpatient, emergency department, or inpatient observation status

排除标准

  • Prior steroid exposure within 90 days of enrollment
  • HgA1c ≥ 6.5 at baseline screening
  • Evidence of concurrent infection
  • Known contraindications to IV steroid treatment
  • History of diabetes mellitus ( type 1 or 2) or severe hypertension
  • Use of any glucose-regulating medications
  • Pregnancy or current use of hormone replacement therapy

结局指标

主要结局

Relapse Recovery & Hyperglycemia

时间窗: Recovery from relapse at 6-months

Determine the relationship between mean postprandial blood glucoses (BG) and relapse recovery (complete vs. incomplete) following a standardized IVMP treatment.

Insulin Resistance & Relapse Severity

时间窗: At Baseline

Determine if insulin resistance (IR), measured by the Matsuda Index, is an independent predictor of relapse severity.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Myla Goldman, MD

Associate Professor of the Department of Neurology

University of Virginia

研究点 (1)

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