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

N/ACompletedNCT01913392

Maisonneuve-Rosemont Hospital15 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Obesity, Morbid Transplant; Failure, Kidney

Interventions

laparoscopic sleeve gastrectomyPROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

MaisonneuveRH

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Baseline and 1 year after bariatric surgery

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 1, 6 and 12 months post-bariatric surgery

Data from ClinicalTrials.gov

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