Bariatric Surgery for ESRD Patients vs Control

NCT00580762 | Terminated DMC

• 1 other identifier: 0508000519
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; ESRD

Outcome Measures

Primary Outcomes (1)

• The safety and efficacy of laparoscopic RYGB in obese ESRD patients will be assessed.

  1 year

Secondary Outcomes (1)

• Weight reduction in ESRD patients will be characterized to assess additive risk factors for micronutrient abnormalities and protein malnutrition.

  1 year

Study Arms (2)

ESRD

EXPERIMENTAL

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)

Non-ESRD

ACTIVE COMPARATOR

Non-ESRD patients who meet the NIH guidelines and preoperative requirements for RYGB will undergo laparoscopic RYGB

Procedure: Roux-en-y gastric bypass (RYGB)

Interventions

Roux-en-y gastric bypass (RYGB) PROCEDURE

ESRD; Non-ESRD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Obesity; Kidney Failure, Chronic

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Sanjay Kulkarni, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Kidney Transplantation

Study Record Dates

• First Submitted: December 18, 2007
• First Posted: December 27, 2007
• Study Start: October 1, 2005
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 7, 2016

Record last verified: 2016-09

Locations

US (1)