Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01913392
Recruitment Status : Completed
First Posted : August 1, 2013
Last Update Posted : December 2, 2019
Sponsor:
Collaborators:
Canadian surgical research fund
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Gabriel Chan, Md, 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.

Condition or disease Intervention/treatment
Obesity, Morbid Transplant; Failure, Kidney 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : July 18, 2013
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. changes in the pharmacokinetics of oral immunosuppressive medications due to bariatric surgery, comparing pre-bariatric surgery to 12 months post-operative [ Time Frame: pre-bariatric surgery and 1 year after surgery ]
    Tacrolimus and Mycophenolate AUC 0-24h

  2. degree of weight loss achieved after bariatric surgery in the chronic renal failure patient. [ Time Frame: baseline and every 3 months ]
    weight, BMI and abdominal circumference measures

  3. Evaluate the change in general quality of life score, SF-36 [ Time Frame: 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 :
  1. evaluate changes to residual renal function in the pre-dialysis renal transplant candidate [ Time Frame: at baseline versus month 12 post-bariatric surgery ]
    serum creatinine/ urea, sodium, potassium, magnesium, calcium, phosphate and bicarbonate pre surgery and month 12

  2. evaluate the change in the number and dose of medications required to treat co-morbidities including, hypertension, hyperlipidemia and diabetes mellitus [ Time Frame: baseline and 12 month post-bariatric surgery ]
    concommitant medication records at baseline vs month 12

  3. the incidence of complications post-bariatric surgery will be evaluated [ Time Frame: 1, 6 and 12 months post-bariatric surgery ]
    non serious and serious adverse events collection at Baseline, month 6 and month 12


Biospecimen Retention:   None Retained
plasma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
morbidly obese, kidney transplant candidate with stage IV or V chronic renal disease
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01913392


Locations
Layout table for location information
Canada, Quebec
MaisonneuveRH
Montréal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital
Canadian surgical research fund
Astellas Pharma Canada, Inc.
Investigators
Layout table for investigator information
Principal Investigator: Gabriel Chan, MD Maisonneuve-Rosemont Hospital
  Study Documents (Full-Text)

Documents provided by Gabriel Chan, Md, Maisonneuve-Rosemont Hospital:
Informed Consent Form  [PDF] May 26, 2016
Study Protocol  [PDF] April 18, 2013


Additional Information:
Layout table for additonal information
Responsible Party: Gabriel Chan, Md, Transplant and general surgeon, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT01913392    
Other Study ID Numbers: 2014-530-13022
First Posted: August 1, 2013    Key Record Dates
Last Update Posted: December 2, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Insufficiency
Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Kidney Diseases
Urologic Diseases