Obesity, Morbid, Transplant; Failure, Kidney
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURElaparoscopic sleeve gastrectomy
Sponsors
Canadian surgical research fund
Astellas Pharma Canada, Inc.
Maisonneuve-Rosemont Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes in the pharmacokinetics of oral immunosuppressive medications due to bariatric surgery, comparing pre-bariatric surgery to 12 months post-operative | 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. | baseline and every 3 months | weight, BMI and abdominal circumference measures |
| Evaluate the change in general quality of life score, SF-36 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | concommitant medication records at baseline vs month 12 |
| the incidence of complications post-bariatric surgery will be evaluated | 1, 6 and 12 months post-bariatric surgery | non serious and serious adverse events collection at Baseline, month 6 and month 12 |
| evaluate changes to residual renal function in the pre-dialysis renal transplant candidate | at baseline versus month 12 post-bariatric surgery | serum creatinine/ urea, sodium, potassium, magnesium, calcium, phosphate and bicarbonate pre surgery and month 12 |
Countries
Canada
Outcome results
None listed