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
About this trial
This is an interventional treatment trial for Severe Obesity focused on measuring Obesity, Renal failure, Gastric bypass
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
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
NCT ID
NCT02128802
First Posted
April 23, 2014
Last Updated
February 2, 2023
Sponsor
Vanderbilt University Medical Center
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
Learn more about this trial
Obesity Surgery and Kidney Transplant for Patients With Obesity and Renal Failure
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