Effect of Laparoscopic Sleeve Gastrectomy in the Morbidly Obese, Kidney Transplant Candidate

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Obesity, Morbid, Transplant; Failure, Kidney

Intervention / Treatment
-----------------
* Procedure: laparoscopic sleeve gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| morbidly obese, chronic renal disease<br>adult patients (> 18 years) who have stage 4 or 5 chronic renal disease (CrCl < 30 ml/min) who are being considered for possible future kidney transplantation. The study inclusion criteria are an indication for laparoscopic sleeve gastrectomy (BMI > 40 kg/m2, or BMI > 35 with at least one co-morbidity such as hypertension, dyslipidemia or diabetes) | Procedure: laparoscopic sleeve gastrectomy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the pharmacokinetics of oral immunosuppressive medications due to bariatric surgery, comparing pre-bariatric surgery to 12 months post-operative | Tacrolimus and Mycophenolate AUC 0-24h | pre-bariatric surgery and 1 year after surgery | 
| degree of weight loss achieved after bariatric surgery in the chronic renal failure patient. | weight, BMI and abdominal circumference measures | baseline and every 3 months | 
| Evaluate the change in general quality of life score, SF-36 | comparison of the SF score between Baseline and month 3, Baseline and month 6 and Baseline and month 12 | Baseline and 1 year after bariatric surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate changes to residual renal function in the pre-dialysis renal transplant candidate | serum creatinine/ urea, sodium, potassium, magnesium, calcium, phosphate and bicarbonate pre surgery and month 12 | at baseline versus month 12 post-bariatric surgery | 
| evaluate the change in the number and dose of medications required to treat co-morbidities including, hypertension, hyperlipidemia and diabetes mellitus | concommitant medication records at baseline vs month 12 | baseline and 12 month post-bariatric surgery | 
| the incidence of complications post-bariatric surgery will be evaluated | non serious and serious adverse events collection at Baseline, month 6 and month 12 | 1, 6 and 12 months post-bariatric surgery |