Incretin Regulation of Insulin Secretion in Monogenic Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incretin Effect
研究概览
简要总结
The purpose of this study is to explore the mechanisms of metabolic control in monogenic diabetes patients treated with sulfonylurea medications.
详细描述
Monogenic diabetes patients and healthy matched controls will be admitted to the University of Chicago Clinical Resource Center for a total of 4 nights. The following will take place on separate days:
- Oral Glucose Tolerance Test (OGTT): consume sugary drink and blood samples will be collected at multiple time points
- Isoglycemic glucose infusion (IGI) test: glucose will be infused via a vein in the arm and and blood samples will be collected at multiple time points
- OGTT during GLP-1 infusion
- IGI during Exendin-9 infusion
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of monogenic diabetes
- •Previously participated in US Neonatal Diabetes Registry (IRB 15617B) or Genetics of diabetes mellitus (IRB 6858)
- •Age: 18 years +
排除标准
- •Pregnancy
- •Acute medical illness or chronic conditions including: cardiac failure, renal insufficiency (estimated glomerular filtration rate <50 ml/min), hepatic insufficiency (known cirrhosis or hepatitis), chronic obstructive pulmonary disease, gastrointestinal disorders causing malabsorption, anemia (Hct < 36%), or uncontrolled hypertension
- •Healthy Controls:
- •Inclusion Criteria:
- •Good general health
- •Stable weight for 6 months
- •Age: 18 years +
- •Exclusion Criteria:
- •Pregnancy
- •Acute medical illness or chronic conditions including: cardiac failure, renal insufficiency (estimated glomerular filtration rate <50 ml/min), hepatic insufficiency (known cirrhosis or hepatitis), chronic obstructive pulmonary disease, gastrointestinal disorders causing malabsorption, anemia (Hct < 36%), or uncontrolled hypertension
研究组 & 干预措施
Healthy controls
Healthy controls will be matched (age, gender, BMI) to monogenic diabetes subjects. Healthy controls will participate in the following:
- OGTT
- IGI
- IGI with GLP-1 infusion
- OGTT with Exendin 9-39 infusion
干预措施: Exendin 9-39 (Drug)
Monogenic diabetes
Monogenic diabetes subjects will be matched (age, gender, BMI) to healthy controls. Monogenic diabetes subjects will participate in the following:
- OGTT
- IGI
- IGI with GLP-1 infusion
- OGTT with Exendin 9-39 infusion
干预措施: Exendin 9-39 (Drug)
Healthy controls
Healthy controls will be matched (age, gender, BMI) to monogenic diabetes subjects. Healthy controls will participate in the following:
- OGTT
- IGI
- IGI with GLP-1 infusion
- OGTT with Exendin 9-39 infusion
干预措施: GLP-1 (Drug)
Monogenic diabetes
Monogenic diabetes subjects will be matched (age, gender, BMI) to healthy controls. Monogenic diabetes subjects will participate in the following:
- OGTT
- IGI
- IGI with GLP-1 infusion
- OGTT with Exendin 9-39 infusion
干预措施: GLP-1 (Drug)
结局指标
主要结局
Incretin Effect
时间窗: Baseline
Directly calculated from the difference between oral and IV stimulated insulin secretion
次要结局
未报告次要终点