Severe Obesity, Renal Failure
Conditions
Keywords
Obesity, Renal failure, Gastric bypass
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.
Interventions
PROCEDUREGastric Bypass
OTHERWeight Loss Program
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 5 years | Number of patients who die from any cause |
| Weight loss | 5 years | Amount of weight lost at various points over the study period |
| 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. |
| 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. |
| Nutritional status | 5 years | This outcome includes but is not limited to measures of albumin, pre-albumin, and caloric intake. |
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Prograf dosing | 5 years | This outcome will assess the amount of prograf required for therapeutic levels |
Countries
United States
Outcome results
None listed