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

Weight Reduction Surgery Followed by Kidney Transplantation for Patients With Class III Obesity and Renal Failure

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

Study Overview

• Status: Active, not recruiting
• Conditions: Renal Failure; Severe Obesity
• Intervention / Treatment: Procedure: Gastric Bypass; Other: Weight Loss Program

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgical Gastric Bypass; Patients will undergo surgical gastric bypass according to standard institutional protocols	Procedure: Gastric Bypass
Experimental: Medical Weight Loss Management; Patients will receive best practices medical management for weight loss under current institutional protocols	Other: Weight Loss Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Number of patients who die from any cause	5 years
Weight loss	Amount of weight lost at various points over the study period	5 years
Surgical outcomes	Incidence of surgical complications including but not limited to leak rate, stricture rate, pulmonary embolism, and infection.	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.	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.	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.	5 years
Nutritional status	This outcome includes but is not limited to measures of albumin, pre-albumin, and caloric intake.	5 years
Hormonal and metabolic status	This outcome includes but is not limited to measurement of protein catabolism, creatinine clearance, and serum prealbumin. In addition, protein and iron metabolism will be measured using serum albumin, transferrin and ferritin. Glucose metabolism will be measured by glucose and insulin levels. regression of the disease. Lipid metabolism will be assessed with triglyceride levels, very-low density lipoproteins, and cholesterol. Micronutrient levels will be measured with vitamin D, thiamin, B12, and folate.	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prograf dosing	This outcome will assess the amount of prograf required for therapeutic levels	5 years

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Seth Karp, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 23, 2014
• First Submitted That Met QC Criteria: April 29, 2014
• First Posted (Estimated): May 1, 2014

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Renal failure; Gastric bypass
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Obesity; Renal Insufficiency; Obesity, Morbid
• Other Study ID Numbers: 130912