The Effect of GLP-1 on Postprandial Glucagon Secretion During Prolonged and Intermittent Stimulation of the GLP-1 Receptor Independent of The Gastric Emptying Rate. A Randomized, Open-label Study in People With Type 1 Diabetes
试验速览
- 阶段
- 2 期
- 入组人数
- 10
- 主要终点
- Glucagon concentration (postprandial)
研究概览
简要总结
Aim: To investigate the glucagonostatic effect of glucagon-like peptide-1 (GLP-1) independent of the gastric emptying rate.
详细描述
Aim: To investigate the glucagonostatic effects of glucagon-like peptide-1 (GLP-1) during prolonged and intermittent stimulation of the GLP-1 receptor independent of the gastric emptying rate. Glucagon concentrations will be measured following a liquid meal administered in duodenum at baseline and after exenatide, and liraglutide treatment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 Diabetes
- •>18 years
- •No residual beta-cell function (stimulated C-peptide < 60 pmol)
排除标准
- •Pancreatitis
- •gastroparesis
- •history of alcohol and/or drug abuse
- •pregnancy and lactation
- •other medical or psychological condition that made the patient unsuitable for study participation according to the investigators´ assessment
- •contraindications to gastroscopy
- •cancer (unless in complete remission > five years)
研究组 & 干预措施
Baseline + Liquid meal test
Baseline day with no additional medication
干预措施: Liquid meal test (Procedure)
Liraglutide + Liquid meal test
Liraglutide 1.2 mg once daily for 14 days (0.6 mg/day for one week, escalated to 1.2 mg/day after one week)
干预措施: Liraglutide (Drug)
Liraglutide + Liquid meal test
Liraglutide 1.2 mg once daily for 14 days (0.6 mg/day for one week, escalated to 1.2 mg/day after one week)
干预措施: Liquid meal test (Procedure)
Exenatide + Liquid meal test
Exenatide 10 mcg twice daily for 14 days (5 mcg twice daily for one week, escalated to 10 mcg twice daily after one week)
干预措施: Exenatide (Drug)
Exenatide + Liquid meal test
Exenatide 10 mcg twice daily for 14 days (5 mcg twice daily for one week, escalated to 10 mcg twice daily after one week)
干预措施: Liquid meal test (Procedure)
Baseline + Liquid meal test
Baseline day with no additional medication
干预措施: No drug (Baseline day) (Other)
结局指标
主要结局
Glucagon concentration (postprandial)
时间窗: 4 hours
glucagon area under the curve (AUC) (0-240 minutes) and baseline to peak increments will be calculated
次要结局
- Postprandial glucose concentrations(4 hours)
- glucagon-like peptide-1 (GLP-1)(4 hours)
- glucagon-like peptide-2 (GLP-2)(4 hours)
- glucose-dependent insulinotropic polypeptide (GIP)(4 hours)
- Cholecystokinin (CCK)(4 hours)
- Peptide YY (PYY)(4 hours)
- Ghrelin(4 hours)
- Gastrin(4 hours)
- Oxyntomodulin(4 hours)
- Free fatty acids (FFA)(4 hours)
- triacylglycerol (TAG)(4 hours)
研究者
Christan SS Frandsen, MD
MD
Hvidovre University Hospital