Determinants of Oral Morphine Answer Among Obese Patients Before and After Gastric Bypass
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- 30mg Oral morphine systemic exposure (AUC 0-24)
研究概览
简要总结
The bariatric surgery is widely used to treat obesity. Roux-en-Y gastric bypass is one of the most frequently surgical methods performed and combines restrictive and malabsorptive procedures. Different data suggest that this surgery may modify drug absorption and we think it would be clinically relevant to describe the consequences of gastric bypass on drug systemic exposure in obese patients, since no data on the comparison between the pharmacokinetics (PK) of a drug before and after surgery are available and help to predict the drugs posology.The investigators decided to study the morphine because there is a lack of information about the PK, pharmacodynamics (PD) et pharmacogenetics (PG) of morphine in obese subjects, in contrary with anaesthetic drugs. This is a drug with a narrow therapeutic range frequently prescribed in obese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Patients aged between 18 and 60 years old.
- •Patients with morbid obesity (IMC > 40 kg/m²) or severe obesity (IMC=35-40 kg/m²) with co morbidities (sleep apnea syndrome or hypertension or steatosis hepatitis) with a favourable decision of a multidisciplinary team for a gastric bypass.
- •Patient agreeing to go 3 times for a one day hospitalisation in the URT of the Lariboisière Hospital for the morphine PK/PD.
- •Patient with a previous medical examination.
- •Patient giving its well-informed and free consent after information.
排除标准
- •concomitant sedative, antidepressive or analgesic treatments or drugs unadvised with morphine
- •untreated sleep apnea syndrom, hypoxia (PaO2<70mmHg) or hypercapnia (PaCO2>45mmHg), anaemia <10g/dL, ASAT or ALAT>3N
研究组 & 干预措施
obemo
干预措施: gastric bypass (Procedure)
结局指标
主要结局
30mg Oral morphine systemic exposure (AUC 0-24)
时间窗: Before surgery-7-15 days after surgery- 6 months after surgery
次要结局
- Morphine and M6G AUC, clearance, Cmax and Tmax(Before surgery-7-15 days after surgery- 6 months after surgery)
- fat mass and total body water (assessed by DEXA and BIA)(before surgery and 6 months following surgery)
- genetic polymorphisms known to affect expression and/or activity of enzymes, receptors and transporters involved in morphine PK/PD (UGT2B7, P-gp, OPRM1, COMT) and morphine PK/PD(Before surgery)
- mRNA and protein expression of P-gp , UGT2B7, MRP2 and MRP3 in intestinal biopsies(obtained from the bariatric surgery)
研究者
Célia LLORET LINARES
MCU-PH
Hopital Lariboisière