Prospective, Clinical Study of the Effect of Bariatric Surgery, Laparoscopic Sleeve Gastrectomy, on the Pharmacokinetics of Immunosuppressive Drugs in the Morbidly Obese, Kidney Transplant Candidate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- changes in the pharmacokinetics of oral immunosuppressive medications due to bariatric surgery, comparing pre-bariatric surgery to 12 months post-operative
研究概览
简要总结
A prospective clinical trial will study the effects of laparoscopic sleeve gastrectomy in the potential renal transplant candidate who is denied acceptance due mainly to the morbid obesity.
详细描述
The remaining factor in determining the effectiveness of bariatric surgery in the transplant population will be to study the effect on the pharmacokinetics of immunosuppressive medication, height, weight, BMI, abdominal circumference, blood pressure, Hba1c , average daily insulin requirements, lipid profile, TSH, 24h urine creatinine clearance and the SF-36 Quality of life questionnaire.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult (>18 years)
- •stage IV and V chronic renal disease (glomerular filtration rate < 30 ml/min,
- •body mass index (BMI) of greater than 40 kg/m2 or > 35 with at least one co-morbidity such as hypertension, dyslipidemia or diabetes
排除标准
- •medically unfit for surgical intervention
- •previous gastric or intestinal surgery
- •active gastric disease
- •pregnancy or lactation
- •known intolerance to tacrolimus or mycophenolic acid
- •awaiting potential multi-organ transplantation
- •active infection
结局指标
主要结局
changes in the pharmacokinetics of oral immunosuppressive medications due to bariatric surgery, comparing pre-bariatric surgery to 12 months post-operative
时间窗: pre-bariatric surgery and 1 year after surgery
Tacrolimus and Mycophenolate AUC 0-24h
degree of weight loss achieved after bariatric surgery in the chronic renal failure patient.
时间窗: baseline and every 3 months
weight, BMI and abdominal circumference measures
Evaluate the change in general quality of life score, SF-36
时间窗: Baseline and 1 year after bariatric surgery
comparison of the SF score between Baseline and month 3, Baseline and month 6 and Baseline and month 12
次要结局
- evaluate changes to residual renal function in the pre-dialysis renal transplant candidate(at baseline versus month 12 post-bariatric surgery)
- the incidence of complications post-bariatric surgery will be evaluated(1, 6 and 12 months post-bariatric surgery)
- evaluate the change in the number and dose of medications required to treat co-morbidities including, hypertension, hyperlipidemia and diabetes mellitus(baseline and 12 month post-bariatric surgery)
研究者
Gabriel Chan, Md
Transplant and general surgeon
Maisonneuve-Rosemont Hospital