Altered Metabolism of Nutrients and Drugs in Obesity and After Obesity Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Probe cocktail drugs concentration-time profile in plasma and urine before LRYGB
研究概览
简要总结
Due to anatomical and physiological changes caused by the Roux-en-Y gastric bypass (RYGB) bariatric surgery, drug bioavailability after the surgery can be altered. Therefore, post-operative dose adjustment in these patients can be required.
The aim of the study was to investigate the effects of laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery on drug pharmacokinetics and cytochrome P450 (CYP) mediated metabolism using a cocktail of nine CYP probe drugs.
The cocktail covers nine main CYP enzymes: melatonin (CYP1A2), nicotine (CYP2A6), bupropion (CYP2B6), repaglinide (CYP2C8), losartan (CYP2C9), omeprazole (CYP2C19/CYP3A4), dextromethorphan (CYP2D6), chlorzoxazone (CYP2E1), midazolam (CYP3A4).
The changes in pharmacokinetic parameters of the drugs as well as modulation of the activity of CYPs are evaluated before and one year after LRYGB. In the study, the patients administering drug cocktail before surgery and 1 year after LRYGB are served as their own controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI > 40 kg/m2 or BMI 35-40 kg/m2 and a comorbidity or its risk factor, such as type 2 diabetes, hypertension, sleep apnea, osteoarthritis of weight bearing joints or polycystic ovarian syndrome;
- •previous conservative treatment for obesity had been proven to be ineffective;
- •patients were assigned to undergo LRYGB surgery
- •patients are able to give a written inform consent.
排除标准
- •consuming alcohol more than 20 g per day were included in the study
- •taking drugs which alter CYPs activity
- •history of hypersensitivity to the drugs used in the cocktail
研究组 & 干预措施
Phenotyping cocktail of 9 CYP probe drugs before surgery
干预措施: cocktail of nine CYP probe drugs (Drug)
Phenotyping cocktail of 9 CYP probe drugs 1 year after surgery
干预措施: cocktail of nine CYP probe drugs (Drug)
结局指标
主要结局
Probe cocktail drugs concentration-time profile in plasma and urine before LRYGB
时间窗: baseline, 1 hour, 2 hour, 4 hour and 6 hour
Probe cocktail drugs concentration-time profile in plasma and urine 1 year after LRYGB
时间窗: baseline, 1 hour, 2 hour, 4 hour and 6 hour
次要结局
- Metabolic ratios of parent compounds and corresponding metabolites before LRYGB(baseline, 1 hour, 2 hour, 4 hour and 6 hour)
- Metabolic ratios of parent compounds and corresponding metabolites 1 year after LRYGB(baseline, 1 hour, 2 hour, 4 hour and 6 hour)
研究者
Jussi Pihlajamäki
Prof.
University of Eastern Finland