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临床试验/NCT02272556
NCT02272556已完成不适用

Investigating the Role of Polyol Pathway in the Central Nervous System

Yale University2 个研究点 分布在 1 个国家目标入组 138 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
138
试验地点
2
主要终点
Metabolite Measurements by MRS

研究概览

简要总结

Patients will undergo magnetic resonance spectroscopy (MRS) scanning to noninvasively measure intracerebral and plasma metabolite levels at baseline and following 2 and 4 hours of hyperglycemia. Subjects will also undergo a lumbar puncture at a separate occasion to assess cerebrospinal fluid levels of metabolites.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 DM with HbA1C treated with metformin, sulfonylurea, insulin, or combination OR age-matched, non-diabetic obese (BMI > 30 kg/m^2) OR age-matched lean, healthy control subjects (BMI < 25 kg/m^2)
  • Age 18-55
  • BMI 18-45 kg/m^2

排除标准

  • Creatinine > 1.5 mg/dL
  • Hgb < 10 mg/dL
  • ALT > 2.5 x ULN
  • Untreated thyroid disease
  • Uncontrolled Hypertension
  • Known Neurological Disorders
  • Untreated Psychiatric Disorders
  • Malignancy
  • Bleeding Disorders
  • Current or recent steroid use in last 3 months
  • Illicit drug use
  • Pregnancy, actively seeking pregnancy, or breastfeeding
  • Inability to enter MRI/MRS

结局指标

主要结局

Metabolite Measurements by MRS

时间窗: 4 hours post hyperglycemia

metabolite levels will be measured by MRS

次要结局

  • Satiety Ratings(4 hours post hyperglycemia)
  • Hunger Ratings(4 hours post hyperglycemia)
  • Cognitive State(4 hours post hyperglycemia)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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