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Completed

NCT Number: NCT01913392

Effect of Laparoscopic Sleeve Gastrectomy 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

MaisonneuveRH

Montreal, Quebec, H1T 2M4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic sleeve gastrectomy

Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Maisonneuve-Rosemont Hospital

Other

Collaborators

  • Astellas Pharma Canada, Inc.
  • Canadian surgical research fund

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Aug 1, 2013
Registry last updated
Dec 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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