Reversibility of Brain Glucose Transport and Metabolism in T2DM
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Brain glucose concentration in the occipital cortex week 0
研究概览
简要总结
The goal of this clinical trial is to learn about the effects of high blood glucose levels in the brain and assess if the changes seen in individuals with poorly control T2DM can be reversed with good glucose control.
The main question[s] it aims to answer are:
- To determine, whether abnormalities in brain glucose transport seen in individuals with uncontrolled diabetes, can be improved with better glucose control.
- Assess which factors, (duration of diabetes mellitus (DM) and glycemic control) contribute to changes in glucose transport
Participants will have:
- A screening visit
- placement of a continuous glucose monitor (CGM) 2 weeks before the first magnetic resonance spectroscopy (MRS) at week 0
- Additional visits/phone calls for intensification of diabetes management and nutrition visits
- Second magnetic resonance spectroscopy (MRS) at week 12
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Male or female, aged 18-60
- •medical history for Type 2 diabetes
- •HbA1c > 7.5%, BMI ≥18 kg/m2
- •Be willing to adhere to the intensification of their diabetes regimen
排除标准
- •Creatinine > 1.5 mg/dL
- •Hgb < 10 mg/dL, hematocrit of 37 % for males participants and 33 % for female participants
- •ALT >3 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
- •for women: pregnancy, actively seeking pregnancy, or breastfeeding
- •inability to enter MRI/MRS (as per standard MRI safety guidelines).
结局指标
主要结局
Brain glucose concentration in the occipital cortex week 0
时间窗: week 0
Intracerebral concentrations of glucose across the occipital cortex , as measured by MRS will be compared following hyperglycemic clamp in T2DM individuals at baseline (week0).
Brain glucose concentration in the occipital cortex week 12
时间窗: week 12
Intracerebral concentrations of glucose across the occipital cortex will be compared between T2DM patients before and after 12 weeks of intensification of their diabetes management.
次要结局
- CGM metrics(weeks 12)