Bariatric Surgery for ESRD Patients vs Control

Stopped early · Not applicable

Conditions studied: Obesity, ESRD

In brief

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.

Key facts

Study ID

NCT00580762

Run by

Yale University

People needed

5

Starts

2005-10-01

Expected to finish

2011-07-01

Last updated by the study team

2016-09-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Yale University School of Medicine — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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