NCT02340247已完成4 期
Effects of Ursodeoxycholic Acid and Chenodeoxycholic Acid on GLP-1 Secretion After Roux-en-Y Gastric Bypass
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- GLP-1 secretion (evaluated by iAUC)
研究概览
简要总结
The purpose of this study is to examine the effects of bile acids on GLP-1 secretion after Roux-en-Y gastric bypass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uncomplicated RYGB performed minimum 3 months prior to the study.
- •Fasting plasma glucose < 7.0mM, HbA1c < 48mmol/mol 3 months after RYGB.
排除标准
- •Fasting plasma glucose > 7.0mM, HbA1c > 48mmol/mol 3 months after RYGB.
- •Dysregulated hypothyroidism, use of antithyroid treatment.
- •Late diabetic complications as retinopathy, renal insufficiency, neuropathy or previous pancreatitis.
- •Complications to RYGB: Documented reactive hypoglycaemia, severe dumping (vomiting, diarrhea, severe abdominal pain after food intake).
研究组 & 干预措施
Placebo
Experimental
150mL water
干预措施: Water (Other)
Ursodeoxycholic acid
Experimental
Ursodeoxycholic acid (750mg) dissolved in 150mL water
干预措施: Ursodeoxycholic Acid (Drug)
Chenodeoxycholic acid
Experimental
Chenodeoxycholic acid (1250mg) dissolved in 150mL water
干预措施: Chenodeoxycholic Acid (Drug)
结局指标
主要结局
GLP-1 secretion (evaluated by iAUC)
时间窗: Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180
次要结局
- PYY secretion (evaluated by iAUC)(Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180)
- Changes in bile acids/FGF-19(Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180)
- Gherlin secretion (evaluated by iAUC)(Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180)
- C-peptide secretion (evaluated by iAUC)(Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180)
- Glucagon secretion (evaluated by iAUC)(Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180)
- TSH/T3/T4(0, 60, 120, 180)
- GIP secretion (evaluated by iAUC)(Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180)
- CCK secretion (evaluated by iAUC)(Baseline, 0, 5, 10, 15, 20, 25, 30, 45, 60, 90, 120, 180)
- Appetite measurements (VAS-score)(Baseline, 30, 60, 120, 180)
研究者
Maria Saur Svane
MD
Hvidovre University Hospital
研究点 (1)
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