Effect of Dapagliflozin on Hepatic and Renal Glucose Metabolism Subjects (11038)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Endogenous Glucose Production Measurement
研究概览
简要总结
Researchers hope to determine the organ (liver and/or kidney) responsible for the increase in endogenous glucose production (EGP) following the induction of glucosuria (when glucose is excreted in detectable amounts in the urine) with an SGLT2 inhibitor, dapagliflozin.
详细描述
Researchers will measure the rate of hepatic and renal glucose production following dapagliflozin administration to determine the site of increase in EGP, liver versus kidney. Researchers will measure the rate of whole body glucose production with 3-3H-glucose (a form of radioactive glucose) and renal glucose production by renal vein catheterization in T2DM (type 2 diabetes mellitus) and in lean healthy NGT (normal glucose tolerance) individuals. Because the increase in EGP is associated with an increase in plasma glucagon concentration and renal glucose production is stated to be unresponsive to glucagon, the investigators anticipate that the liver will be responsible, in part, for the increase in EGP.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •25-35 kg/m^2
- •Normal Glucose Tolerance subjects (24)
- •Type 2 Diabetic Subjects (24)
- •Diabetic subjects must be on a stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea
- •Diabetic subjects must have HbA1c <8.0%
- •Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, blood chemistries, CBC (complete blood count), TSH (thyroid-stimulating hormone), T4 (thyroxine), EKG (electrocardiogram) and urinanalysis.
- •Only subjects whose body weight has been stable (± 3 lbs) over the preceding three months and who do not participate in an excessively heavy exercise program will be included.
排除标准
- •Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea) will be excluded.
- •Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine >1.4 females or >1.5 males, or 24-hour urine albumin excretion > 300 mg will be excluded.
研究组 & 干预措施
T2DM individuals on Dapagliflozin
Individuals with type 2 diabetes mellitus - dapagliflozin
干预措施: Dapagliflozin (Drug)
T2DM individuals on Placebo
Individuals with type 2 diabetes mellitus on placebo
干预措施: Placebo (Drug)
Normal Glucose Tolerance (NGT) on Dapagliflozin
Individuals with normal glucose tolerance - dapagliflozin
干预措施: Dapagliflozin (Drug)
Normal Glucose Tolerance (NGT) Placebo
Individuals with normal glucose tolerance - on placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Endogenous Glucose Production Measurement
时间窗: 3 weeks
Endogenous Glucose Production in NGT/T2DM subjects before and after dapagliflozin/Placebo administration from baseline to 240 minutes.
次要结局
- Renal Glucose Production Measurement of Change(Baseline to 3 weeks)