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

Completed

• Conditions: Obesity, Morbid; Transplant; Failure, Kidney
• Interventions: Procedure: laparoscopic sleeve gastrectomy

• Registration Number: NCT01913392
• Lead Sponsor: Maisonneuve-Rosemont Hospital

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.

Study Timeline

• Study Start: 2013-07-18
• Study First Submitted: 2013-07-30
• Study First Submitted QC: 2013-07-31
• Study First Posted: 2013-08-01
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-27
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
morbidly obese, chronic renal disease	laparoscopic sleeve gastrectomy	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)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 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

Trial Locations

Locations (1)

MaisonneuveRH; 🇨🇦 Montréal, Quebec, Canada