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

Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02128802
• Other study ID #: 130912
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2014
• Est. completion date: December 2025

Study information

• Verified date: February 2024
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid
• Renal Failure
• Renal Insufficiency
• Severe Obesity

Intervention

Procedure:
• Gastric Bypass

Other:
• Weight Loss Program

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prograf dosing	This outcome will assess the amount of prograf required for therapeutic levels	5 years
Primary	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	All-cause mortality	Number of patients who die from any cause	5 years
Secondary	Weight loss	Amount of weight lost at various points over the study period	5 years
Secondary	Surgical outcomes	Incidence of surgical complications including but not limited to leak rate, stricture rate, pulmonary embolism, and infection.	5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Nutritional status	This outcome includes but is not limited to measures of albumin, pre-albumin, and caloric intake.	5 years
Secondary	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