跳至主要内容
临床试验/NCT04018105
NCT04018105已完成不适用

Influence of Preprandial Metformin Administration on Carbohydrate Absorption: Pilot Randomized Controlled Study

University Hospital, Lille0 个研究点目标入组 1 人开始时间: 2021年7月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
主要终点
Area under the curve of D-Xylose

研究概览

简要总结

Type 2 diabetes is spreading worldwide as well as obesity. Metformin is the most prescribed antidiabetic medication. One suggested mechanism of action is by decreasing carbohydrate absorption.

It is usually recommended to take metformin during the meal to decrease gastrointestinal side effects. However, if metformin decreases carbohydrate absorption, this might not be the most efficient intake.

To study the influence of preprandial metformin administration on carbohydrate absorption, it will repeat 3 oral glucose tolerance test on obese dysglycemic patients, without metformin or with metformin administer 30 or 60 minutes before. We will also evaluate how it impacts gastrointestinal tolerance.

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 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Obesity (BMI ≥30 kg/m2)
  • Dysglycemia (HbA1c≥ 6,0 %)
  • No anti diabetic medication

排除标准

  • No obesity (BMI < 30 kg/m2)
  • No dysglycemia (HbA1c <6,0%)
  • Treatment that might interfere with carbohydrate absorption (anti diabetic medication, antibiotics, probiotics, steroids)
  • Anemia (Hb <12 g/dL)
  • Organ failure
  • Inflammatory Bowel Disease

研究组 & 干预措施

taking metformin 30 or 60 minutes before the OGTT

Experimental

干预措施: Oral glucose tolerance test (OGTT) with or without metformin (Other)

No metformin before OGTT

Placebo Comparator

干预措施: Oral glucose tolerance test (OGTT) with or without metformin (Other)

结局指标

主要结局

Area under the curve of D-Xylose

时间窗: During the 3 hours OGTT

次要结局

  • Area under the curve of blood glucose(During the 3 hours OGTT)
  • Number of Participants with gastrointestinal side effects(During the 3 hours OGTT)
  • Area under the curve of insulin(During the 3 hours OGTT)
  • Area under the curve of GLP-1(During the 3 hours OGTT)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

相似试验