Effects of a GLP-1 Receptor Agonist on Functional Activation and Connectivity of the Brain Measured by Functional MRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Difference of BOLD (Blood oxygenation level-dependent) signal in hypothalamus
研究概览
简要总结
The aims this study is to explore the effect of a GLP-1 receptor agonist on the degree of brain activation and connectivity obtained by functional magnetic resonance imaging in lean and obese type 2 diabetes
详细描述
Fifteen lean [BMI(body mass index) less than 23 kg/m2] type 2 diabetes subjects and fifteen obese (BMI more than 26 kg/m2) subjects with type 2 diabetes treated by diet and/or metformin, SU(sulfonylurea), DPP4-inhibitors(Dipeptidyl peptidase-4 inhibitor) will be recruited. Every subject will be studied on 2 separate days in random order with 1-2 week intervals. These participants will be injected either normal saline or 10 mcg of lixisenatide in a cross-over fashion. Neuroimaging composed with resting-12-min, visual stimulation task-12-min, T1-5-min, and diffusion tensor image-12-min will be proceeded. Ad lib buffet will be provided to every participant and the intake will be measured. Surveys about appetite and mood will be done before and after neuroimaging test and buffet eating.
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
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI ≤ 23kg/m2 or BMI ≥ 26kg/m2
- •participants with diabetes treated by diet or oral antidiabetic drug, HbA1c less than 8.5%
排除标准
- •Those who diagnosed by Type 1 diabetes
- •History of insulin therapy
- •Aspartate aminotransferase(AST) or Alanine transaminase(ALT) >2.5 times of upper normal reference range
- •Estimated Glomerular Filtration Rate(eGFR) <30 mL/min/1.73m2
- •Those who can't be performed MRI
研究组 & 干预措施
Lixisenatide injection
intervention : Lyxumia® pen injection 10 microgram (Lixisenatide) subcutaneous injection 30 minutes before functional MRI
干预措施: Lixisenatide (Drug)
Normal saline
control : normal saline 0.3 cc subcutaneous injection before functional MRI
干预措施: Placebo (Other)
结局指标
主要结局
Difference of BOLD (Blood oxygenation level-dependent) signal in hypothalamus
时间窗: 10min (40 min after injection)
Whole brain connectivity
时间窗: 20min (50 min after injection)
次要结局
- intake of food in the buffet(50min)
- mood change(-30min, 45min(after fMRI), 70min(after buffet))
- appetite change(-30min, 45min(after fMRI), 70min(after buffet))