Sitagliptin's Effects on Glucose-stimulated Insulin Secretion and Oral Glucose
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Sitagliptin-induced enhancement of early insulin secretion
研究概览
简要总结
This is a research study to find out how different people respond to a medication called sitagliptin. Sitagliptin is an FDA approved medication that is used to treat diabetes. We are asking for healthy, non-diabetic volunteers to participate in this 7-week study. If you agree to participate, you will take part in 2 clinic visits that are 4-6 weeks apart. At the clinic visits you will have an oral glucose tolerance test (OGTT) and other blood tests to see how your body processes glucose (sugar). An OGTT is a test in which your drink glucose and then blood samples are taken afterward at specific time points to measure glucose and insulin in your blood. Each clinic visit will last about 5 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Age: >18 years old
- •Members of Old Order Amish community in Lancaster, PA
排除标准
- •• Pregnancy (reproductive age women will undergo pregnancy tests immediately before receiving the drug)
- •Diabetes: HbA1c > 6.5% or fasting plasma glucose >126 mg/dL
- •Estimated glomerular filtration rates (eGFR) <60 mL/min/1.73 m2
- •Anemia: hematocrit < 35%
- •Thyroid status: TSH<0.4 or TSH>5.5
- •ALT or AST in excess of 2X upper limit of normal
- •Drugs that in the physician's judgment would alter response to sitagliptin
- •Significant health issues that in the physician's judgment could increase the risk for participants.
研究组 & 干预措施
Sitagliptin
Sitagliptin 100 mg given 2 hours prior to the oral glucose tolerance test
干预措施: Oral Glucose Tolerance Test (Procedure)
Placebo
Placebo given 2 hours prior to the oral glucose tolerance test
干预措施: Oral Glucose Tolerance Test (Procedure)
结局指标
主要结局
Sitagliptin-induced enhancement of early insulin secretion
时间窗: 6 weeks
This represents the incretinomimetic effect of sitagliptin, which contributes importantly to the mechanism whereby DPP4is decrease HbA1c in T2D patients. Because histograms for sitagliptin-induced increase in our index of early insulin secretion (T30:T60) demonstrated a skewed distribution, we will apply a logarithmic transformation of data which yields a normal distribution. Thus, the drug effect is defined as: log(T30:T60 ins)sita - log(T30:T60 ins)control.
Sitagliptin-induced change in glucose tolerance
时间窗: 6 weeks
Sitagliptin-induced change in glucose tolerance. This is a consequence of enhanced insulin secretion, which reflects most closely the desired effect of the drug to decrease plasma glucose and decrease HbA1c. Because histograms for sitagliptin-induced increase in our index of glucose tolerance (T30:T60) demonstrated a skewed distribution, we will apply a logarithmic transformation of data which yields a normal distribution. Thus, the drug effect is defined as: log(T30:T60 gluc)sita - log(T30:T60 gluc)control.
次要结局
- Area under the curve for insulin concentration(6 weeks)
- Area under the curve for glucose concentration(6 weeks)
- Area under the curve for intact GIP(6 weeks)
- Area under the curve for intact GLP1(6 weeks)
- Area under the curve for C-peptide levels(6 weeks)
研究者
Amber Beitelshees
Professor
University of Maryland, Baltimore