Bariatric Surgery for ESRD Patients vs Control - Full Text View

Sponsored by:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00580762

Purpose

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	Intervention
Obesity ESRD	Procedure: Roux-en-y gastric bypass (RYGB)

MedlinePlus related topics: Kidney Transplantation Obesity Weight Control Weight Loss Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Obesity, End-Stage Renal Disease and Kidney Transplantation

Further study details as provided by Yale University:

Primary Outcome Measures:

The safety and efficacy of laparoscopic RYGB in obese ESRD patients will be assessed. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Weight reduction in ESRD patients will be characterized to assess additive risk factors for micronutrient abnormalities and protein malnutrition. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	October 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Obese ESRD patients with a BMI≥ 40kg/m2 or ≥35kg/m2 with an medical complication attributed to morbid obesity (NIH guidelines). Age ≥ 18 and ≤ 65	Procedure: Roux-en-y gastric bypass (RYGB) Procedure is done laparoscopically while subject is anticipating renal transplant.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00580762

Contacts

Contact: Lisa Fox, RN	203-688-8371	Lisa.Fox@ynhh.org
Contact: Noelle Sowers, RN	203-785-2068	Noelle.Sowers@yale.edu

Locations

United States, Connecticut
Yale University School of Medicine	Recruiting
New Haven, Connecticut, United States, 06510
Contact: Lisa Fox, RN 203-688-8371 Lisa.Fox@ynhh.org
Contact: Noelle Sowers, RN 203-785-2068 Noelle.Sowers@yale.edu
Principal Investigator: Sanjay Kulkarni, MD

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator:

Sanjay Kulkarni, MD

Yale University

More Information

Responsible Party:	Yale University School of Medicine ( Sanjay Kulkarni, MD )
Study ID Numbers:	0508000519
Study First Received:	December 18, 2007
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00580762
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Kidney Failure, Chronic

Nutrition Disorders
Overweight
Overnutrition
Kidney Diseases

ClinicalTrials.gov processed this record on January 13, 2009