Obesity Surgery and Kidney Transplant for Patients With Obesity and Renal Failure
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|ClinicalTrials.gov Identifier: NCT02128802|
Recruitment Status : Recruiting
First Posted : May 1, 2014
Last Update Posted : February 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Severe Obesity Renal Failure||Procedure: Gastric Bypass Other: Weight Loss Program||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Weight Reduction Surgery Followed by Kidney Transplantation for Patients With Class III Obesity and Renal Failure|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Experimental: Surgical Gastric Bypass
Patients will undergo surgical gastric bypass according to standard institutional protocols
Procedure: Gastric Bypass
Experimental: Medical Weight Loss Management
Patients will receive best practices medical management for weight loss under current institutional protocols
Other: Weight Loss Program
- 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) [ Time Frame: 18 months ]Outcomes will be measured based on weight loss and a variety of validated surveys and questionnaires to measure HRQOL
- All-cause mortality [ Time Frame: 5 years ]Number of patients who die from any cause
- Weight loss [ Time Frame: 5 years ]Amount of weight lost at various points over the study period
- Surgical outcomes [ Time Frame: 5 years ]Incidence of surgical complications including but not limited to leak rate, stricture rate, pulmonary embolism, and infection.
- Development or regression of diabetes [ Time Frame: 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 [ Time Frame: 5 years ]Development or regression of other diseases including but not limited to hypertension, coronary artery disease, and skin infections.
- Health care utilization [ Time Frame: 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 [ Time Frame: 5 years ]This outcome includes but is not limited to measures of albumin, pre-albumin, and caloric intake.
- Hormonal and metabolic status [ Time Frame: 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.
- Prograf dosing [ Time Frame: 5 years ]This outcome will assess the amount of prograf required for therapeutic levels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128802
|Contact: Seth Karp, MDfirstname.lastname@example.org|
|Contact: Andrea W Reed, MS||(615) email@example.com|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator: Seth Karp, MD|