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| Name | Class |
|---|---|
| Canadian surgical research fund | UNKNOWN |
| Astellas Pharma Canada, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic sleeve gastrectomy | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| evaluate the change in the number and dose of medications required to treat co-morbidities including, hypertension, hyperlipidemia and diabetes mellitus |
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Inclusion Criteria:
Exclusion Criteria:
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morbidly obese, kidney transplant candidate with stage IV or V chronic renal disease
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| Name | Affiliation | Role |
|---|---|---|
| Gabriel Chan, MD | Maisonneuve-Rosemont Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MaisonneuveRH | Montreal | Quebec | H1T 2M4 | Canada |
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| Label | URL |
|---|---|
| Prospective Study of the Changes in Pharmacokinetics of Immunosuppressive Medications after Laparoscopic Sleeve Gastrectomy | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 26, 2016 | Nov 14, 2019 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 18, 2013 | Nov 27, 2019 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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plasma
concommitant medication records at baseline vs month 12 |
| baseline and 12 month post-bariatric surgery |
| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |