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

Obesity, Morbid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01913392
• Other study ID #: 2014-530-13022
• Status: Completed
• Start date: July 18, 2013
• Est. completion date: May 2018

Study information

• Verified date: November 2019
• Source: Maisonneuve-Rosemont Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid
• Renal Insufficiency
• Transplant; Failure, Kidney

Intervention

Procedure:
• laparoscopic sleeve gastrectomy

Locations

Country	Name	City	State
Canada	MaisonneuveRH	Montréal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Maisonneuve-Rosemont Hospital	Astellas Pharma Canada, Inc., Canadian surgical research fund

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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

External Links

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