NCT02420392已完成不适用
Effects of Dapagliflozin on the Incretin Sensitivity of the Pancreatic Beta Cell
适应症
干预措施
相关药物
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 incretin sensitivity of pancreatic beta cell measured by hyperglycemic clamp with GLP-1 and GIP infusion
研究概览
简要总结
To investigate the effect of dapagliflozin on the incretin sensitivity of the pancreatic beta cell.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetes for dapagliflozin arm
- •Normal glucose tolerance (fasting plasma glucose <100 mgd/l, HbA1c <6.0%) for normal glucose tolerance arm
- •Age 18 to 75 years
- •BMI <35 kg/m2
- •For type 2 diabetes patients, at least 3 months of treatment period and HbA1c 7.5 to 11.0% and treatment with lifestyle modification and/or metformin or sulfonylurea
排除标准
- •Who is allergic to dapagliflozin
- •Type 1 diabetes
- •Patients with history of diabetic ketoacidosis
- •Reduced renal function (eGFR <60ml/min/1.73m2)
- •Taking loop diuretics or dehydrated patient
- •History of hypotension when taking hypertensive medication
- •Diagnosed with heart failure
- •Diagnosed with cerebral infarction
- •Taking insulin, DPP-4 inhibitor, GLP-1 analogue, pioglitazone, alpha-glucosidase inhibitor
- •Above upper limit of normal hematocrit range (male 39-52%, female 36-48%)
- •Pregnant or breastfeeding women
- •History of recurrent genitourinary infection
- •AST/ALT more than two fold increased above normal upper limit
- •Hemolytic disorder
研究组 & 干预措施
Dapagliflozin treatment
Experimental
Test incretin sensitivity after dapagliflozin treatment in type 2 diabetes patients
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Difference of incretin sensitivity of pancreatic beta cell measured by hyperglycemic clamp with GLP-1 and GIP infusion
时间窗: From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp
Area under the curve of C-peptide level during GLP-1 infusion under hyperglycemic clamp
次要结局
- First phase insulin/C-peptide response(From 0 to 10 minutes of hyperglycemic clamp)
- Second phase insulin/C-peptide response(From 10 to 60 minutes of hyperglycemic clamp)
- Area under the curve of insulin level during GLP-1 infusion under hyperglycemic clamp(From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp)
- Difference of Area under the curve of insulin/C-peptide level during GIP infusion under hyperglycemic clamp between diabetes patients and normal glucose tolerance subjects(From 120 minutes to 180 minutes during GIP infusion under hyperglycemic clamp)
- Area under the curve of insulin/C-peptide level during GIP infusion under hyperglycemic clamp(From 120 minutes to 180 minutes during GIP infusion under hyperglycemic clamp)
- Difference of incretin sensitivity between diabetes patients and normal glucose tolerance subjects(From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp)
- Difference of first phase insulin/C-peptide response between diabetes patients and normal glucose tolerance subjects(From 0 to 10 minutes of hyperglycemic clamp)
- Difference of second phase insulin/C-peptide response between diabetes patients and normal glucose tolerance subjects(From 10 to 60 minutes of hyperglycemic clamp)
- Difference of area under the curve of insulin level during GLP-1 infusion under hyperglycemic clamp between diabetes patients and normal glucose tolerance subjects(From 60 minutes to 120 minutes during GLP-1 infusion under hyperglycemic clamp)
研究者
Young Min Cho
Assistant Professor
Seoul National University Hospital
研究点 (1)
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