Clinical trial NCT01913392: Effect of Laparoscopic Sleeve Gastrectomy in the Morbidly Obese, Kidney Transplant Candidate
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity, Morbid
Transplant; Failure, Kidney
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
Collaborators: name: Canadian surgical research fund
name: Astellas Pharma Canada, Inc.
First posted: 2013-08-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: morbidly obese, kidney transplant candidate with stage IV or V chronic renal disease

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.

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

Primary outcomes:
measure: changes in the pharmacokinetics of oral immunosuppressive medications due to bariatric surgery, comparing pre-bariatric surgery to 12 months post-operative
timeFrame: pre-bariatric surgery and 1 year after surgery
measure: degree of weight loss achieved after bariatric surgery in the chronic renal failure patient.
timeFrame: baseline and every 3 months
measure: Evaluate the change in general quality of life score, SF-36
timeFrame: Baseline and 1 year after bariatric surgery
Secondary outcomes:
measure: evaluate changes to residual renal function in the pre-dialysis renal transplant candidate
timeFrame: at baseline versus month 12 post-bariatric surgery
measure: evaluate the change in the number and dose of medications required to treat co-morbidities including, hypertension, hyperlipidemia and diabetes mellitus
timeFrame: baseline and 12 month post-bariatric surgery
measure: the incidence of complications post-bariatric surgery will be evaluated
timeFrame: 1, 6 and 12 months post-bariatric surgery
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: MaisonneuveRH
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Gabriel Chan, MD
role: PRINCIPAL_INVESTIGATOR
References: