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

Maisonneuve-Rosemont Hospital

Status: Completed

Conditions: Transplant; Failure, Kidney; Obesity, Morbid

Treatments: Procedure: laparoscopic sleeve gastrectomy

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01913392

2014-530-13022

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

15 participants in 1 patient group

morbidly obese, chronic renal disease

Description:

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)

Treatment:

Procedure: laparoscopic sleeve gastrectomy