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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-18

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obesity, Morbid Transplant; Failure, Kidney

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

Interventions

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laparoscopic sleeve gastrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No