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Trial record 2 of 79 for:    vanderbilt | Kidney Failure | Nashville, Tennessee, U.S.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02128802
Recruitment Status : Recruiting
First Posted : May 1, 2014
Last Update Posted : June 18, 2021
Information provided by (Responsible Party):
Seth Karp, 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.

Condition or disease Intervention/treatment Phase
Severe Obesity Renal Failure Procedure: Gastric Bypass Other: Weight Loss Program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 5 years ]
    Number of patients who die from any cause

  2. Weight loss [ Time Frame: 5 years ]
    Amount of weight lost at various points over the study period

  3. Surgical outcomes [ Time Frame: 5 years ]
    Incidence of surgical complications including but not limited to leak rate, stricture rate, pulmonary embolism, and infection.

  4. 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.

  5. 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.

  6. 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.

  7. Nutritional status [ Time Frame: 5 years ]
    This outcome includes but is not limited to measures of albumin, pre-albumin, and caloric intake.

  8. 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.

Other Outcome Measures:
  1. Prograf dosing [ Time Frame: 5 years ]
    This outcome will assess the amount of prograf required for therapeutic levels

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02128802

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Contact: Sheri Dixon, RN BSN 615-343-0266

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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Seth Karp, MD         
Sponsors and Collaborators
Vanderbilt University Medical Center
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Principal Investigator: Seth Karp, MD Vanderbilt University Medical Center
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Responsible Party: Seth Karp, Professor, Vanderbilt University Medical Center Identifier: NCT02128802    
Other Study ID Numbers: 130912
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: June 2021
Keywords provided by Seth Karp, Vanderbilt University Medical Center:
Renal failure
Gastric bypass
Additional relevant MeSH terms:
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Renal Insufficiency
Obesity, Morbid
Nutrition Disorders
Body Weight
Kidney Diseases
Urologic Diseases