Obesity Surgery and Kidney Transplant for Patients with Obesity and Renal Failure
- Conditions
- Severe ObesityRenal Failure
- Interventions
- Procedure: Gastric BypassOther: Weight Loss Program
- Registration Number
- NCT02128802
- Lead Sponsor
- Vanderbilt University Medical Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- Body mass index 40-55 kg/m2
- Age less than 60 years
- Available support person
- Adequate insurance
- All other criteria required for renal transplantation
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgical Gastric Bypass Gastric Bypass Patients will undergo surgical gastric bypass according to standard institutional protocols Medical Weight Loss Management Weight Loss Program Patients will receive best practices medical management for weight loss under current institutional protocols
- Primary Outcome Measures
Name Time Method 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) 18 months Outcomes will be measured based on weight loss and a variety of validated surveys and questionnaires to measure HRQOL
- Secondary Outcome Measures
Name Time Method Weight loss 5 years Amount of weight lost at various points over the study period
Nutritional status 5 years This outcome includes but is not limited to measures of albumin, pre-albumin, and caloric intake.
All-cause mortality 5 years Number of patients who die from any cause
Health care utilization 5 years 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.
Hormonal and metabolic status 5 years 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.
Surgical outcomes 5 years Incidence of surgical complications including but not limited to leak rate, stricture rate, pulmonary embolism, and infection.
Development or regression of diabetes 5 years 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 5 years Development or regression of other diseases including but not limited to hypertension, coronary artery disease, and skin infections.
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States