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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical Gastric Bypass | Experimental | Patients will undergo surgical gastric bypass according to standard institutional protocols |
|
| Medical Weight Loss Management | Experimental | Patients will receive best practices medical management for weight loss under current institutional protocols |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric Bypass | Procedure |
| ||
| Weight Loss Program |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prograf dosing | This outcome will assess the amount of prograf required for therapeutic levels | 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seth Karp, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D051437 | Renal Insufficiency |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| D061217 | Weight Reduction Programs |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
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|
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D005763 |
| Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |
| D006293 | Health Promotion |
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |