Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Complications in Diabetic Patients: A Proof of Concept Study.
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
- 否
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
David McDougal
Assistant Professor
Pennington Biomedical Research Center