Evaluating Glial Acetate Metabolism as a Biomarker of Hypoglycemic Counterregulation Using 13C Magnetic Resonance Spectroscopy.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS)
研究概览
简要总结
Hypoglycemic complications are a major impediment to the maintenance of healthy glucose levels in persons with diabetes. The investigators recently completed a clinical pilot and feasibility study (GLIMPSE, NCT02690168), which identified a novel biomarker, glial acetate metabolism, that appears to predict the susceptibility to hypoglycemia. By providing an assay to predict hypoglycemic events and therefore diabetic complications, the development of this biomarker could significantly improve the treatment of persons with diabetes.
The goal of this study is to determine the efficacy of our biomarker for predicting susceptibility to insulin-induced hypoglycemia. In order to accomplish this goal the investigatiors will pair our 13C magnetic resonance spectroscopy procedure to assess glial acetate metabolism, developed in the GLIMPSE study, with a hyperinsulinemic-hypoglycemic clamp procedure, developed in the HYPOCLAMP study (NCT03839511). The two procedures will be separated by a three day interval. The investigators will then correlate the participants' rates of glial acetate metabolism with their neuroendocrine responses to the hypoglycemic clamp. This proof of concept study will test the hypothesis that glial acetate metabolism is inversely proportional to the neuroendocrine response to hypoglycemia, that is, as glial acetate metabolism increases the neuroendocrine response will decrease.
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
- 是
入选标准
- •Healthy male or female
- •Ages 18-40 years
- •BMI between 20 kg/m2 and 30 kg/m2 (±0.5 kg/m2 will be accepted)
- •Medically cleared for participation in the study
排除标准
- •Contraindication to MRI
- •Consume >10 alcoholic drinks/week
- •History of chronic smoking or have quit less than 10 years ago
- •History of clinically diagnosed diabetes or a fasting blood glucose >126 mg/dL
- •Average screening blood pressure >140/90 mmHg
- •History of cardiovascular disease
- •Pregnant, planning to become pregnant, or breastfeeding
- •Use of medications affecting glucose metabolism, e.g., benzodiazepines, thiazide diuretics, cortisone, and prednisone.
- •Use of beta-adrenergic antagonists.
- •Based on the investigative team's clinical judgement, a subject may not be appropriate for participation in the study.
研究组 & 干预措施
Arm 1
Participants will have their glial acetate metabolism measured by carbon-13 magnetic resonance spectroscopy as well as their neuroendocrine response to hypoglycemia 3 days later.
干预措施: hyperinsulinemic-hypoglycemic clamp (Other)
Arm 1
Participants will have their glial acetate metabolism measured by carbon-13 magnetic resonance spectroscopy as well as their neuroendocrine response to hypoglycemia 3 days later.
干预措施: 13C-MRS procedure/Acetate infusion (Other)
结局指标
主要结局
Percent 13C enrichment of bicarbonate measured via carbon-13 magnetic resonance spectroscopy (13C-MRS)
时间窗: Every ten minutes for 120 minutes following administration of 1-13C acetate
Glial acetate metabolism
次要结局
- Change in serum epinephrine levels(epinephrine will be measured every 15 minutes for 135 minutes.)
研究者
David McDougal
Assistant Professor
Pennington Biomedical Research Center