Mechanisms for Restoration of Hypoglycemia Awareness
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Brain Glucose Levels
研究概览
简要总结
To assess if using the hypoglycemic clamp and functional magnetic resonance imaging (fMRI) scanning in hypoglycemia unaware and aware T1DM patients and healthy controls have showed distinct differences in patterns of brain responses. In particular, T1DM patients who are aware of hypoglycemia (T1DM-Aware) have greater activity in sensory integration brain regions (e.g. parietal lobe and caudate nucleus) in response to hypoglycemia, whereas hypoglycemia unaware T1DM patients (T1DM-Unaware) show no detectable changes in brain reward regions during hypoglycemia.
详细描述
To assess the following: 1) if these differences are driven purely by recurrent hypoglycemia or by other closely linked factors (e.g. glycemic variability); 2) the molecular and metabolic mechanisms by which unawareness leads to the suppression of central nervous system (CNS) activity in the context of hypoglycemia; and 3) whether hypoglycemia avoidance using continuous glucose monitor restores central nervous system (CNS) activation and metabolism toward normal levels and offers a therapeutic approach to more effectively combat neurocognitive dysfunction associated with intensive treatment of T1DM patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
blinded
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages > 18 years
- •Healthy, non-diabetic control or T1DM
- •BMI > 18.0
排除标准
- •Creatinine > 1.5 mg/dL
- •Hct < 35% for females, < 39% for males
- •ALT > 2.5 X ULN
- •untreated thyroid disease
- •uncontrolled hypertension
- •neurologic disorders
- •untreated depression or change in antidepressant regimen in last 3 months
- •use of any anxiolytic medications (benzodiazepine) or antipsychotic medications
- •greater than 5% change in weight in last 3 months
- •malignancy
- •current or recent steroid use in last 3 months
- •illicit drug use
- •significant complications related to diabetes (peripheral neuropathy, proliferative retinopathy)
- •inability to enter MRI (per standard MRI safety guidelines)
- •for women: pregnancy or breastfeeding
研究组 & 干预措施
Aim 3: Type 1 diabetes mellitus user unaware subjects 3 months
Continuous Glucose Monitor for 3 months duration
干预措施: Continuous Glucose Monitor (CGM) (Device)
Aim 3: Type 1 diabetes mellitus user unaware subjects 3 months
Continuous Glucose Monitor for 3 months duration
干预措施: Insulin (Drug)
Aim 1: Impact of hypoglycemia on brain connectivity Type 1
Healthy controls, T1 aware, and T1 unawares
干预措施: Insulin (Drug)
Aim 2: Impact of hypoglycemia on brain glucose transports in Type 1
Healthy controls, T1 aware, and T1 unawares
干预措施: Insulin (Drug)
结局指标
主要结局
Brain Glucose Levels
时间窗: 3 months
Regional quantification of brain glucose levels with MRS (CMRgl) will be used to measure group differences.
次要结局
未报告次要终点