The Effect of HMG-CoA Reductase Inhibition on Postprandial GLP-1 Secretion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Postprandial GLP-1 secretion
研究概览
简要总结
The primary objective of the present study is to evaluate the effect of HMG-CoA reductase inhibition during 14 days on the postprandial plasma GLP-1 response in healthy individuals. Secondary objectives include the evaluation of HMG-CoA reductase inhibition on postprandial glucose tolerance, gallbladder emptying, gastric emptying, plasma responses of lipids, bile acids and pancreatic and enteric hormones known to influence glucose metabolism and appetite, and faecal content of bile acids and gut microbiota composition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) >18.5 kg/m2 and <35 kg/m2
- •Caucasian ethnicity
- •Normal haemoglobin
- •Glycated haemoglobin (HbA1c) <43 mmol/mol
- •Fasting plasma glucose <6 mmol/l
- •Informed and written consent
排除标准
- •First-degree relatives with diabetes (both type 1 diabetes and type 2 diabetes)
- •Liver disease (serum alanine aminotransferase (ALAT) and/or serum aspartate aminotransferase (ASAT) >2 times normal values) or history of hepatobiliary disorder
- •Gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery
- •Reduced kidney function or nephropathy (estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2 (based on serum creatinine) and/or albuminuria
- •Taking any kind of medicine on a regular basis
- •Intake of antibiotics two months prior to study
- •Active or recent malignant disease
- •Any treatment or condition requiring acute or sub-acute medical or surgical intervention
- •Any condition considered incompatible with participation by the investigators
- •If the subjects receive any antibiotic treatment while included in the study they will be excluded
研究组 & 干预措施
Atorvastatin
2 weeks treatment with Atorvastatin (1st week 40 mg once daily on day, 2nd week 80 mg (2x40mg) once daily)
干预措施: Atorvastatin (Drug)
Placebo
2 weeks treatment with placebo tablets of comparable sizes and color to the Atorvastatin tablets (1st week one tablet once daily, 2nd week two tablets once daily)
干预措施: Placebo (Other)
结局指标
主要结局
Postprandial GLP-1 secretion
时间窗: 240 min
次要结局
- Postprandial Bile Acid Composition(240 min)
- Postprandial total plasma Bile Acid(240 min)
- Postprandial Glucose Tolerance(240 min)
- Postprandial plasma lipid response(240 min)
- Postprandial GIP secretion(240 min)
- Enteric hormones known to influence glucose metabolism(240 min)
- Gallbladder emptying(240 min)
- Faecal content of bile acid(One sample collected on day 12 or 13 of the intervention)
- Gut microbiota composition(One sample collected on day 12 or 13 of the intervention)
- Gastric emptying(240 min)
- Resting Energy Expenditure(At time -20 min, +60 min and +220 min)
研究者
Filip Krag Knop
Professor
University Hospital, Gentofte, Copenhagen