Bariatric Surgery for ESRD Patients vs Control

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. Read our disclaimer for details. Identifier: NCT00580762
Recruitment Status : Terminated (Lack of enrollment)
First Posted : December 27, 2007
Last Update Posted : September 7, 2016
Information provided by (Responsible Party):
Sanjay Kulkarni, Yale University

Brief Summary:
This study will address a true clinical problem by developing a risk/benefit analysis for rapid surgical weight loss in the ESRD population. The risks of surgical intervention, as well as, potential nutritional concerns, balanced with that of the potential medical benefits associated with significant weight loss.

Condition or disease Intervention/treatment Phase
Obesity ESRD Procedure: Roux-en-y gastric bypass (RYGB) Not Applicable

Detailed Description:
The study will be designed to compare two cohorts of patients that will undergo laparoscopic RYGB. Cohort 1 will include ESRD patients on HD who meet the NIH guidelines and preoperative requirements for RYGB. Cohort 2 will include non-ESRD patients who meet the NIH guidelines and preoperative requirements for RYGB. Laparoscopic RYGB will be performed in ESRD patients who meet the guidelines recommended by the National Institutes of Health consensus statement . This includes patients who either have a BMI≥40 kg/m2 or have a BMI≥35 kg/m2 and have a significant morbidity attributed to their obesity (i.e. sleep apnea, hypertension, and diabetes mellitus). All patients will undergo a complete pre-operative evaluation inclusive of dietary instruction, assessment of surgical risk, psychosocial evaluation and compliance evaluation. This evaluation will be conducted through an existing infrastructure at the investigators Bariatric Surgery Center. Patients will be required to be on hemodialysis or able to be converted to hemodialysis for the perioperative period. All procedures will be performed by the same team of surgeons, experienced in both laparoscopic RYGB, organ transplantation and general surgery in ESRD patients. The risks involved with Roux-en-Y gastric bypass surgery will be discussed with the patient. These risks are inherent to the procedure, however the procedure is being conducted for medical appropriate reasons and therefore the benefits to the procedure outweigh the risks. At the present time, it is believed, without any justification, that this procedure is more risky or too risky in the ESRD population. A primary objective of this study is to investigate this question.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Obesity, End-Stage Renal Disease and Kidney Transplantation
Study Start Date : October 2005
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: ESRD
End-Stage Renal Disease (ESRD) patients on dialysis who meet the NIH guidelines and preoperative requirements for RYGB will undergo laparoscopic RYGB
Procedure: Roux-en-y gastric bypass (RYGB)
Active Comparator: Non-ESRD
Non-ESRD patients who meet the NIH guidelines and preoperative requirements for RYGB will undergo laparoscopic RYGB
Procedure: Roux-en-y gastric bypass (RYGB)

Primary Outcome Measures :
  1. The safety and efficacy of laparoscopic RYGB in obese ESRD patients will be assessed. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Weight reduction in ESRD patients will be characterized to assess additive risk factors for micronutrient abnormalities and protein malnutrition. [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Obese ESRD patients with a BMI≥ 40kg/m2 or ≥35kg/m2 with an medical complication attributed to morbid obesity (NIH guidelines).REF
  2. Age ≥ 18 and ≤ 65
  3. Patients must be on hemodialysis for one month.
  4. Patients listed for kidney transplant in a UNOS certified kidney transplant center.
  5. Patients have accrued less than 18 months of waiting time.
  6. Completion of pre-RYGB psychosocial evaluation.
  7. Completion of pre-RYGB dietary counseling.
  8. Completion of pre-RYGB surgical risk assessment inclusive of cardiac evaluation.
  9. Full reciprocal understanding of informed consent and the risks and benefits of RYGB procedure.
  10. Acceptance of clinical protocol evaluations requiring scheduled clinic visits and laboratory blood draws.

Exclusion Criteria:

  1. Age < 18 and > 65.
  2. Patients with a history of peritoneal dialysis related bacterial peritonitis.
  3. Peritoneal dialysis patients not willing to undergoing temporary hemodialysis.
  4. History of difficult vascular access as defined by the inability to obtain permanent upper extremity or temporary jugular venous access.
  5. History of poor hemodialysis performance.
  6. Patients enrolled in another study within 6 months of initiation.
  7. Patients listed for kidney transplant in a different UNOS region that has shorter transplant waiting times than the region governing the investigators institution.
  8. Patients unwilling to be made temporarily unavailable for transplant.
  9. History of non-compliance with medical care.
  10. Uncontrolled psychiatric illness (ie. depression, anxiety, attention deficit disorder (ADD), uncontrolled binge eating disorder)
  11. Inability to provide reciprocal understanding of informed consent.
  12. Failure to complete the preoperative work-up (psychosocial, dietary and surgical risk) for RYGB.

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): NCT00580762

United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Principal Investigator: Sanjay Kulkarni, MD Yale University

Responsible Party: Sanjay Kulkarni, Director of Kidney Transplantation, Yale University Identifier: NCT00580762     History of Changes
Other Study ID Numbers: 0508000519
First Posted: December 27, 2007    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms