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Bariatric Surgery for ESRD Patients vs Control

Primary Purpose

Obesity, ESRD

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Roux-en-y gastric bypass (RYGB)

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ESRD

Non-ESRD

Arm Description

End-Stage Renal Disease (ESRD) patients on dialysis who meet the NIH guidelines and preoperative requirements for RYGB will undergo laparoscopic RYGB

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00580762

First Posted

December 18, 2007

Last Updated

September 2, 2016

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT00580762

Brief Title

Bariatric Surgery for ESRD Patients vs Control

Official Title

Obesity, End-Stage Renal Disease and Kidney Transplantation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Terminated

Why Stopped

Lack of enrollment

Study Start Date

October 2005 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yale University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, ESRD

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ESRD

Arm Type

Experimental

Arm Description

End-Stage Renal Disease (ESRD) patients on dialysis who meet the NIH guidelines and preoperative requirements for RYGB will undergo laparoscopic RYGB

Arm Title

Non-ESRD

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Roux-en-y gastric bypass (RYGB)

Primary Outcome Measure Information:

Title

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

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

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sanjay Kulkarni, MD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

12. IPD Sharing Statement

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Bariatric Surgery for ESRD Patients vs Control

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