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

NCT ID: NCT02128802

Last Updated: 2025-03-10

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

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-01

Study Completion Date

2024-03-28

Brief Summary

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

Detailed Description

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Conditions

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Severe Obesity Renal Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Surgical Gastric Bypass

Patients will undergo surgical gastric bypass according to standard institutional protocols

Group Type EXPERIMENTAL

Gastric Bypass

Intervention Type PROCEDURE

Medical Weight Loss Management

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

Group Type EXPERIMENTAL

Weight Loss Program

Intervention Type OTHER

Interventions

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Gastric Bypass

Intervention Type PROCEDURE

Weight Loss Program

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Seth Karp

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Seth Karp, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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130912

Identifier Type: -

Identifier Source: org_study_id

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