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临床试验/NCT04430660
NCT04430660已完成不适用

Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients: A Proof of Concept Study.

Pennington Biomedical Research Center4 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2020年8月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
4
主要终点
Change in percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS)

研究概览

简要总结

A recent pilot study, GLIMPSE (NCT02690168), was recently completed which demonstrated that the rate of glial acetate metabolism (GAM) is closely associated with susceptibility to fasting-induced hypoglycemia in healthy adults. Insulin-induced hypoglycemia is a common complication of diabetes treatment and is a major barrier to the maintenance of healthy glucose levels in individuals with diabetes. The primary purpose of the study is to test the proof-of-concept that there is an association between the rate of GAM and susceptibility to insulin-induced hypoglycemia. In order to observe such a relationship the rate of GAM will be measured in a patient population known to frequently experience hypoglycemia, i.e., individuals with type 1 diabetes mellitus (T1DM).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female
  • Ages 18-40 years
  • Diagnosed with type 1 diabetes with positive antibodies or dependent on insulin therapy
  • HbA1c of ≤8.5%
  • Modified Clarke's Hypoglycemia Questionnaire score of 12-24
  • Willing to participate in continuous glucose monitoring (CGM)

排除标准

  • Contraindication to MRI
  • Consume >10 alcoholic drinks/week
  • Current use of CGM
  • Current use of insulin pump
  • Current use of any diabetes medication other than insulin, e.g. SGLT1/2 inhibitors.
  • Current use of steroids, e.g. cortisone, and prednisone.
  • History of chronic smoking or have quit less than 10 years ago
  • History of cancer in the past 5 years (individuals with basal cell or squamous cell skin cancer would be allowed)
  • History of seizures
  • Significant, cardiac, vascular, pulmonary, gastrointestinal, neurologic, hematologic, rheumatologic, or psychiatric disease
  • Significant liver disease as defined as more than twice the upper limit of normal for liver enzymes
  • Significant renal disease as defined as a estimated glomerular filtration rate less than 30
  • Pregnant, planning to become pregnant, or breastfeeding
  • Have been hospitalized or treated in the past 3 months for severe hypoglycemia
  • Based on the investigative team's clinical judgement, a subject may not be appropriate for participation in the study.

结局指标

主要结局

Change in percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS)

时间窗: Once at Study Visit 1 day and 1 day at Study Visit 3, 14 days apart

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

David McDougal

Assistant Professor

Pennington Biomedical Research Center

研究点 (4)

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