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

Study Overview
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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.

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

Conditions
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Severe Obesity, Renal Failure

Intervention / Treatment
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* Procedure: Gastric Bypass
* Other: Weight Loss Program


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surgical Gastric Bypass<br>Patients will undergo surgical gastric bypass according to standard institutional protocols | Procedure: Gastric Bypass<br> <br> |
| Experimental: Medical Weight Loss Management<br>Patients will receive best practices medical management for weight loss under current institutional protocols | Other: Weight Loss Program<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Number of patients who die from any cause | 5 years | 
| Weight loss | Amount of weight lost at various points over the study period | 5 years | 
| Surgical outcomes | Incidence of surgical complications including but not limited to leak rate, stricture rate, pulmonary embolism, and infection. | 5 years | 
| 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 | 
| 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 | 
| 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 | 
| Nutritional status | This outcome includes but is not limited to measures of albumin, pre-albumin, and caloric intake. | 5 years | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Renal failure, Gastric bypass