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Completed

NCT Number: NCT02128802

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

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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Key information

Conditions

Severe Obesity Body Weight Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Renal Failure Renal Insufficiency Signs and Symptoms Urogenital Diseases Urologic Diseases

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gastric bypass

Procedure

Weight Loss Program

Other

Primary outcomes

  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 outcomes

  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 outcomes

  1. Prograf dosing

    Time frame: 5 years

    This outcome will assess the amount of prograf required for therapeutic levels

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2021
Study completion
2024
First posted
May 1, 2014
Registry last updated
Mar 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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