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

Primary Purpose

Severe Obesity, Renal Failure

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Gastric Bypass
Weight Loss Program
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Obesity focused on measuring Obesity, Renal failure, Gastric bypass

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Surgical Gastric Bypass

Medical Weight Loss Management

Arm Description

Patients will undergo surgical gastric bypass according to standard institutional protocols

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

All-cause mortality
Number of patients who die from any cause
Weight loss
Amount of weight lost at various points over the study period
Surgical outcomes
Incidence of surgical complications including but not limited to leak rate, stricture rate, pulmonary embolism, and infection.
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.
Development or regression of other comorbidities
Development or regression of other diseases including but not limited to hypertension, coronary artery disease, and skin infections.
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.
Nutritional status
This outcome includes but is not limited to measures of albumin, pre-albumin, and caloric intake.
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.

Full Information

First Posted
April 23, 2014
Last Updated
February 2, 2023
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02128802
Brief Title
Obesity Surgery and Kidney Transplant for Patients With Obesity and Renal Failure
Official Title
Weight Reduction Surgery Followed by Kidney Transplantation for Patients With Class III Obesity and Renal Failure
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Obesity, Renal Failure
Keywords
Obesity, Renal failure, Gastric bypass

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Surgical Gastric Bypass
Arm Type
Experimental
Arm Description
Patients will undergo surgical gastric bypass according to standard institutional protocols
Arm Title
Medical Weight Loss Management
Arm Type
Experimental
Arm Description
Patients will receive best practices medical management for weight loss under current institutional protocols
Intervention Type
Procedure
Intervention Name(s)
Gastric Bypass
Intervention Type
Other
Intervention Name(s)
Weight Loss Program
Primary Outcome Measure Information:
Title
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)
Description
Outcomes will be measured based on weight loss and a variety of validated surveys and questionnaires to measure HRQOL
Time Frame
18 months
Secondary Outcome Measure Information:
Title
All-cause mortality
Description
Number of patients who die from any cause
Time Frame
5 years
Title
Weight loss
Description
Amount of weight lost at various points over the study period
Time Frame
5 years
Title
Surgical outcomes
Description
Incidence of surgical complications including but not limited to leak rate, stricture rate, pulmonary embolism, and infection.
Time Frame
5 years
Title
Development or regression of diabetes
Description
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
Title
Development or regression of other comorbidities
Description
Development or regression of other diseases including but not limited to hypertension, coronary artery disease, and skin infections.
Time Frame
5 years
Title
Health care utilization
Description
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
Title
Nutritional status
Description
This outcome includes but is not limited to measures of albumin, pre-albumin, and caloric intake.
Time Frame
5 years
Title
Hormonal and metabolic status
Description
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.
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Prograf dosing
Description
This outcome will assess the amount of prograf required for therapeutic levels
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seth Karp, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

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

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