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

NCT01913392 | Completed

• 1 other identifier: 2014-530-13022
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid; Transplant; Failure, Kidney

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• evaluate changes to residual renal function in the pre-dialysis renal transplant candidate

  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

  baseline and 12 month post-bariatric surgery

• the incidence of complications post-bariatric surgery will be evaluated

  1, 6 and 12 months post-bariatric surgery

Study Arms (1)

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

Interventions

laparoscopic sleeve gastrectomy PROCEDURE

morbidly obese, chronic renal disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Maisonneuve-Rosemont Hospital: lead
• Canadian surgical research fund: collaborator
• Astellas Pharma Canada, Inc.: collaborator

Study Sites (1)

MaisonneuveRH

Montreal, Quebec, H1T 2M4, Canada

Location

Related Links

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

Biospecimen

Retention: NONE RETAINED

plasma

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gabriel Chan, MD

  Maisonneuve-Rosemont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Transplant and general surgeon

Study Record Dates

• First Submitted: July 30, 2013
• First Posted: August 1, 2013
• Study Start: July 18, 2013
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: December 2, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)