Obesity Surgery and Kidney Transplant for Patients With Obesity and Renal Failure

Vanderbilt University Medical Center20 enrolled

Overview

Gastric Bypass followed by renal transplantation is superior to medical management followed by renal transplant for patients with severe obesity and renal failure.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Severe Obesity Renal Failure

Interventions

Gastric BypassPROCEDURE

Weight Loss ProgramOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 59 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Body mass index 40-55 kg/m2 * Age less than 60 years * Available support person * Adequate insurance * All other criteria required for renal transplantation Exclusion Criteria: * Schizophrenia * Bipolar disorder * Crohn's disease * Human Immunodeficiency Virus * Cirrhosis * Prior weight loss surgery * Prior mesh hernia repair * Prior anti-reflux surgery * Inability to walk 200 feet * Significant coronary disease * Significant lung disease - Fixed expiratory volume 1 less than 75% or on oxygen * Addiction to alcohol or drugs * Inability to quit smoking * Jehovah's witness * Non-compliance with dialysis regimen * Previous renal transplant * Non-English speaking

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

Ability to reach medical suitability for renal transplant within 18 months after initiating treatment and the change and trajectory of health-related quality of life (HRQOL)

Outcomes will be measured based on weight loss and a variety of validated surveys and questionnaires to measure HRQOL

Time frame: 18 months

Secondary Outcomes

All-cause mortality

Number of patients who die from any cause

Time frame: 5 years

Weight loss

Amount of weight lost at various points over the study period

Time frame: 5 years

Surgical outcomes

Incidence of surgical complications including but not limited to leak rate, stricture rate, pulmonary embolism, and infection.

Time frame: 5 years

Development or regression of diabetes

Including but not limited to start of stop of insulin therapy, amount of insulin required, and start or stop of or cal medications.

Time frame: 5 years

Development or regression of other comorbidities

Development or regression of other diseases including but not limited to hypertension, coronary artery disease, and skin infections.

Time frame: 5 years

Health care utilization

This outcome measure includes but is not limited to the amount of money spent on health care, total hospitalization, days of hospitalization, and procedures required.

Time frame: 5 years

Data from ClinicalTrials.gov

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