Phenotypical Approach of the Drug Metabolizing Hormones Activity (CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4 and P-gp) Before and After Roux-en Y-Gastric Bypass. The SODA Protocol: Surgery for Obesity and Drug Availability
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Phenotypical markers of enzymes and transporter activity
研究概览
简要总结
The activity of drug-metabolizing enzymes and transporters evolutes after Roux-en-Y gastric Bypass.
Primary aim : To study the intra individual evolution of phenotypical markers of different drug metabolizing enzymes and one transporter (CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP3A4 and P-gp), using a cocktail phenotypic approach, after Roux-en-Y gastric Bypass.
详细描述
Principal Judgement criteria :
Phenotypical markers of enzymes and transporter activity before, at 5-8 weeks and 25-30 weeks following surgery.
Secondary judgement criteria :
- Genetic polymorphisms known to affect expression and/or activity of enzymes and transporter.
- Intestinal and hepatic expression and activity of the enzymes and transporter of interest.
- Markers of inflammation Methodology, study design : open-labelled monocentric study.
Sample size : It will be a descriptive experimental study involving 12 subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients with morbid obesity (IMC > 40 kg/m²) or severe obesity (IMC=35-40 kg/m²) with co morbidities (sleep apnea syndrome or hypertension without treatment or steatosis hepatitis) candidates for a gastric bypass.
- •Patient not receiving more than two treatments whose effect on the expression of enzymes and drug transporters is zero other than vitamins.
- •Patient agreeing to participate at three studies of one day (12 hours) occurring at three different periods.
- •Patients aged between 18 and 60 years old.
- •Patient giving its well-informed and free consent.
- •Patient without allergy to any of the drugs used for test.
- •Patients living in France during the study and with French social security
排除标准
- •Contraception including estrogens compounds
- •Medication other than vitamins.
研究组 & 干预措施
phenotypical approach
phenotypical approach
干预措施: phenotypical approach (Drug)
结局指标
主要结局
Phenotypical markers of enzymes and transporter activity
时间窗: 25-30 weeks
plasmatic \[Paraxanthine/caffeine\] ratio (T4H) at 25-30 weeks following surgery. - plasmatic \[Omeprazole/5-hydroxyomeprazole\] ratio (T4H) at 25-30 weeks following surgery. - urinary Log (dextromethorphan/dextrorphan) (T0-T8h) at 25-30 weeks following surgery. - urinary Losartan/ E-3174 (T0-8h) at 25-30 weeks following surgery. - plasmatic AUC 0-inf midazolam at 25-30 weeks following surgery. - plasmatic AUC 0-inf digoxin at 25-30 weeks following surgery
次要结局
- Intestinal and hepatic expression and activity of the enzymes and transporter of interest and markers of inflammation(before surgery)