Treatment With Sitagliptin Phosphate in Patients With Reactive Hypoglycemia Secondary to Dysinsulinism. A Controlled, Randomized, Double-blind, Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical improvement assessed by a validated questionnaire
研究概览
简要总结
The purpose of this study is to determine whether sitagliptin is effective in the treatment of reactive hypoglycemia by dysinsulinism.
详细描述
Symptomatic reactive hypoglycemia is an abnormal glucose decrease after meal ingestion. Patients with this abnormality as an early manifestation of glucose intolerance are at higher risk of type 2 diabetes. The pathophysiology of this abnormality appears to be related with delayed first phase insulin release. Improvement of first phase insulin secretion and delay in gastric emptying induced by sitagliptin phosphate could have favorable effects in patients in whom delayed insulin secretion is associated with reactive hypoglycemia.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and biochemical diagnosis of prediabetic reactive hypoglycemia
- •Must be able to swallow tablet
- •Negative pregnancy test (when appropriate)
排除标准
- •Renal insufficiency
- •Hepatic insufficiency
- •Diabetes (any type)
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Sitagliptin
干预措施: Sitagliptin phosphate (Drug)
结局指标
主要结局
Clinical improvement assessed by a validated questionnaire
时间窗: 2 weeks
次要结局
- Glucose, insulin, GLP1, GIP(First and last evaluations)