Effects of Lansoprazole on Sitagliptin Glucose-lowering Ability in Healthy Males
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Glucose Tolerance
研究概览
简要总结
Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this therapeutic strategy. The investigators sought to examine the effect of PPI lansoprazole, DPP-4 inhibitor sitagliptin, and their combination therapy on insulin and glucose regulation in healthy subjects in oral glucose tolerance (OGTT).
详细描述
Oral hypoglycemic medications sometimes do not control type 2 diabetes well. Proton pump inhibitors (PPIs) as adjunctive therapy might improve diabetes control and could enhance the hypoglycemic activity of DPP4, but there is little clinical data on efficacy of this therapeutic strategy. We sought to examine the effect of PPI (lansoprazole), DPP4 (sitagliptin), and their combination therapy on insulin and glucose regulation in healthy subjects in oral glucose tolerance (OGTT).
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •General good health condition
- •Male subject, between 18 and 50 years
- •Exclusion Criteria
- •Overweight (Body Mass Index ≥30)
- •Metabolic disorders
- •History of gastrointestinal disorders
- •Regular (daily) intake of medication
- •Smoking more than 10 cigarettes/day
- •History of drug abuse
- •Exhaustive (> 3 units/day) alcohol consumption
- •Exhaustive (> 5 units/day) caffeine consumption (coffee, tea, cola, or other caffeine based drinks)
- •Recent (in the last 14 days) donation of blood
- •Recent (in the last 2 days) donation of blood plasma
- •Participation in another trial within 4 weeks before the start of the study
排除标准
- 未提供
研究组 & 干预措施
Combination of lansoprazole and sitagliptin
oral sitagliptin 100 mg on day 6 after administration of lansoprazole (30 mg per day) for 6 days
干预措施: lansoprazole, 30 mg per day for 6 days (Drug)
结局指标
主要结局
Glucose Tolerance
时间窗: 0, 15, 30, 60, 90, 120, 180 min. after glucose administration
次要结局
- Plasma insulin and C-peptide concentrations during oral glucose tolerance test(0, 15, 30, 60, 90, 120, 180 min. after glucose administration)