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

Vanderbilt University Medical Center

Status: Completed

Conditions: Renal Failure; Severe Obesity

Treatments: Procedure: Gastric Bypass; Other: Weight Loss Program

Study type: Interventional

Funder types: Other

Identifiers

NCT02128802

130912

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Surgical Gastric Bypass

Experimental group

Description:

Patients will undergo surgical gastric bypass according to standard institutional protocols

Treatment:

Procedure: Gastric Bypass

Medical Weight Loss Management

Experimental group

Description:

Patients will receive best practices medical management for weight loss under current institutional protocols

Treatment:

Other: Weight Loss Program