Effect of Exenatide on Brain Glucose Uptake in Relations to Pancreatic, Adipose Tissue, and Hepatic Function
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism
研究概览
简要总结
This research study will examine brain glucose metabolism after an overnight fast to determine the effect of exenatide on brain glucose metabolism and lipid metabolism.
详细描述
This study will elucidate if exenatide has an effect on brain glucose metabolism. This will be accomplished by measuring the rate of glucose binding in various brain regions by Positron Emission Tomography (PET) after glucose load with exenatide injection and compare it with placebo injection measured in the same subject. The changes will be compared with peripheral and hepatic glucose metabolism and lipolysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males age 18-65 years old
- •Patients must have Body Mass Index (BMI) between 25 and 40 kg/m2
- •2-hour glucose concentration above 140mg/dl after 75g glucose load, ie, having impaired glucose tolerance or newly diagnosed type 2 diabetes.
- •Patients must have BMI of 25-40 kg/m2
- •Patients must have no known severe liver or kidney disease, cancer, neurologic, psychiatric or systemic disease, ability to understand the study.
- •Only patients whose body weight has been stable (±3-4 pounds) over the three months prior to study will be included.
- •Patients must have the following laboratory values:
- •Hematocrit ≥ 34 vol%
- •Serum creatinine* ≤ 1.5 mg/dl in males and
- •Aspartate aminotransferase (AST) serum glutamic oxaloacetic transaminase (SGOT): ≤ 2.5 times upper limit of normal
- •Alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT): ≤ 2.5 times upper limit of normal
- •Alkaline phosphatase ≤ 2.5 times upper limit of normal
- •If serum creatinine is ≤ 1.5 mg/dl in males, the PI can grant an exception and not exclude the patient if the Glomerular filtration rate (GFR) is >70 ml/min
排除标准
- •Patients are excluded from participation in the study if they meet any of the following criteria:
- •Patients with major chronic illness (cancer, liver, kidney, cardiovascular disease)
- •Patients with BMI over 40 and under 25
- •Patient with age below 18 yrs and over 65 yrs
- •Female subjects
- •Patients with type 1 diabetes
- •Patients treated for type 2 diabetes
- •Subjects with normal glucose tolerance (NGT)
研究组 & 干预措施
Exenatide first, then Placebo
Exenatide 5mcg was injected subcutaneously 30 min before Oral Glucose Tolerance Test (OGTT)-PET study. The same subject was studied again a few weeks later with the same protocol with Placebo injection.
干预措施: Exenatide (Drug)
Exenatide first, then Placebo
Exenatide 5mcg was injected subcutaneously 30 min before Oral Glucose Tolerance Test (OGTT)-PET study. The same subject was studied again a few weeks later with the same protocol with Placebo injection.
干预措施: Placebo (Drug)
Placebo first, then Exenatide
Placebo was injected subcutaneously 30 min before OGTT-PET study. The same subject was studied again a few weeks later with the same protocol with injection of Exenatide 5mcg .
干预措施: Exenatide (Drug)
Placebo first, then Exenatide
Placebo was injected subcutaneously 30 min before OGTT-PET study. The same subject was studied again a few weeks later with the same protocol with injection of Exenatide 5mcg .
干预措施: Placebo (Drug)
结局指标
主要结局
Effect of Exenatide on Brain (Total Gray Matter) Glucose Metabolism
时间窗: 120 minutes after exenatide or placebo injection
To study the acute effect of exenatide on brain glucose metabolism after the glucose load. Brain glucose uptake will be determined from serial FDG PET-imaging, by using graphical methods to quantify both global and regional results. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject.
次要结局
- Effect of Exenatide on the Liver and Adipose Tissue Glucose Uptake(60 minutes after exenatide or placebo injection)
研究者
Ralph DeFronzo
Professor
The University of Texas Health Science Center at San Antonio