Restoring Brain Metabolism and Function in Older Adult T1DM Patients Using an AP System
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Brain Alternate Fuel Uptake
研究概览
简要总结
To demonstrate that a new insulin pump system can prevent low glucose episodes and improve brain function in aged Type 1 diabetes mellitus subjects.
详细描述
The goals of this proposal are to implement a Close-Loop/Artificial Pancreas (CL/AP) system in older patients with type 1 diabetes mellitus (T1DM) in order to reverse brain metabolic adaptations and restore metabolic sensitivity, hypoglycemia awareness and appropriate hormonal counterregulatory responses (CRR). For purposes of this study we are looking to enroll aged T1DM subjects under insulin pump treatment.
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
The intervention consists of treatment with a CL/AP-enabled insulin pump/CGM combination; subjects in the control group will continue their usual diabetes care (insulin pump therapy) along with CGM recording .
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide signed and dated informed consent form
- •Male or female
- •Age 50-75 years (at least 50% over the age of 65)
- •T1DM (>20 years duration)
- •C-peptide undetectable
- •HbA1c of < 8%
- •Insulin pump therapy
- •History of frequent hypoglycemia with unawareness (defined as 2 or more episodes of severe hypoglycemia within one year requiring assistance) and 2 or more glucose values < 54 mg/dL during the week of Continuous Glucose Monitoring (CGM) (iPRO monitor, Medtronic) prior to enrollment
- •BMI <27 kg/m2
- •Good general health as evidenced by medical history and blood screening
- •Willing to comply with all study procedures and be available for the duration of the study
- •Willing to fast for a limited time period on the morning of a clamp study
排除标准
- •Significant diabetic complications (untreated proliferative retinopathy, creatinine ≥1.5 mg/dl, urinary albumin levels 300 mg/day, autonomic neuropathy, painful peripheral neuropathy)
- •Significant alcohol intake and vegetarian diet since both are known to have an impact on counterregulation and brain metabolism
- •Any contraindications for MRI scanning, including presence of metallic implants or claustrophobia.
- •Heavy exercise on a regular basis (i.e. marathon runners)
- •Known allergic reactions to components of the study product(s)
- •Treatment with another investigational drug or other intervention
- •Active infection including hepatitis C, hepatitis B, HIV
- •Any past or current history of alcohol or substance abuse
- •Psychiatric or neurological disorders under active treatment
- •Baseline hemoglobin < 10.5 g/dL in females, or < 12.5 g/dL in males. Blood donation within 30 days of the study
- •History of coagulopathy or medical condition requiring long-term anticoagulant therapy (low-dose aspirin treatment is allowed)
- •Co-existing cardiac, liver, and kidney disease
- •Abnormal liver function tests
- •Women that are on oral contraceptives, post-menopausal, pregnant (as assessed by pregnancy test that will be performed on female participants at reproductive age), or lactating.
- •Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes
结局指标
主要结局
Brain Alternate Fuel Uptake
时间窗: Baseline to 8 - 10 weeks
Change in brain alternate fuel uptake under hypoglycemia was measured by assessing the percent enrichment of Glutamine 4 (Gln4). Change was measured by subtracting follow up from baseline. Astrocytic glutamine C4 enrichment is a measure of brain acetate metabolism (an alternate fuel to glucose). Previous studies have shown that in people who have been exposed to frequent hypoglycemic episodes, glutamine C4 enrichment increases. Therefore, we expected a reduction in Glutamine C4 percent enrichment in the follow up NMR scans in the intervention group who avoided frequent hypoglycemic episodes through the CL/AP system. In addition, there is no specific cut off value used for Glutamine C4 enrichment, rather a change or reduction was expected and noted."
次要结局
- Change in Cognitive Function: MOCA(Baseline to 8-10 weeks)
- Change in Cognitive Function: Trail Test A(Baseline to 8-10 weeks)
- Change in Cognitive Function: Trail Test B(Baseline to 8-10 weeks)
- Change in Cognitive Function: Grooved Pegboard Test(Baseline to 8-10 weeks)