Effects of Chenodeoxycholic Acid and Colesevelam on GLP-1 Secretion, During a Meal, After Roux-en-Y Gastric Bypass
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 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 acid and bile acids sequestrants on GLP-1 Secretion, during a meal, in patients after Roux-en-Y gastric bypass.
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
- 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 < 7,0 mM, HbA1c < 48 mmol/mol 3 months after RYGB
排除标准
- •Fasting plasma glucose > 7,0 mM, HbA1c > 48 mmol/mol 3 months after RYGB.
- •Dysregulated thyroid diseases, 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).
- •Cholecystectomy
研究组 & 干预措施
Placebo
Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM.
25 ml water
干预措施: Water (Other)
Chenodeoxycholic Acid
Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Chenodeoxycholic acid (1250 mg) mixed in 25 ml yoghurt
干预措施: Chenodeoxycholic Acid (Drug)
Colesevelam
Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Colesevelam (3,75 g) dissolved in 25 ml water and mixed in 25 ml yoghurt.
干预措施: Colesevelam (Drug)
Colesevelam x 2
plus (on another study day) 3,75 g colesevelam administered the evening before the experiment. Morning meal: brown bread, margarine, cheese, yoghurt, oatmeal, raisins, almonds, water, PCM. Colesevelam (3,75 g) dissolved in 25 ml water and mixed in 25 ml yoghurt.
干预措施: Colesevelam (Drug)
结局指标
主要结局
GLP-1 secretion (evaluated by iAUC)
时间窗: -10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes after mixed meal
次要结局
- Insulin secretion(-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes)
- PYY secretion(-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes)
- Bile acids/FGF19 concentrations(-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes)
- Glucose levels(-10, 0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes)
- PCM levels(Baseline, 0, 5, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240 minutes)
- CCK secretion(0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes)
- Total bile acid secretion(0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes)
- Appetite measurements (VAS-score)(0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes)
- C-peptide secretion(Baseline, 0, 5, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes)
- Glucagon secretion(Baseline, 0, 10, 20, 30, 45, 60, 90, 120, 180, 240 minutes)
- GIP secretion(0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes)
- Ghrelin(0, 10, 20, 30, 45, 60, 90, 120, 180 and 240 minutes)
研究者
Maria Saur Svane
MD
Hvidovre University Hospital