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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity, Morbid; Transplant; Failure, Kidney
• Intervention / Treatment: Procedure: laparoscopic sleeve gastrectomy

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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1T 2M4
      • MaisonneuveRH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

morbidly obese, kidney transplant candidate with stage IV or V chronic renal disease

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
morbidly obese, chronic renal disease; 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

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

Collaborators and Investigators

• Sponsor: Maisonneuve-Rosemont Hospital
• Collaborators: Astellas Pharma Canada, Inc.; Canadian surgical research fund
• Investigators: Principal Investigator: Gabriel Chan, MD, Maisonneuve-Rosemont Hospital

Publications and helpful links

Helpful Links

• Prospective Study of the Changes in Pharmacokinetics of Immunosuppressive Medications after Laparoscopic Sleeve Gastrectomy

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2013
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: July 30, 2013
• First Submitted That Met QC Criteria: July 31, 2013
• First Posted (Estimate): August 1, 2013

Study Record Updates

• Last Update Posted (Actual): December 2, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Renal Insufficiency; Obesity, Morbid
• Other Study ID Numbers: 2014-530-13022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO