ObesityNCT00580762
Bariatric Surgery for ESRD Patients vs Control
A study testing Roux-en-y gastric bypass (RYGB) in people with Obesity and ESRD, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- What is being tested?
- Roux-en-y gastric bypass (RYGB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06510
About this study
Official title: Obesity, End-Stage Renal Disease and Kidney Transplantation
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.
Read the 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.
- Being tested
- Roux-en-y gastric bypass (RYGB)
- Medical subject headings
- Obesity, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Roux-en-y gastric bypass (RYGB)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| ESRD | Experimental | End-Stage Renal Disease (ESRD) patients on dialysis who meet the NIH guidelines and preoperative requirements for RYGB will undergo laparoscopic RYGB Receives: 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 Receives: Procedure: Roux-en-y gastric bypass (RYGB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and efficacy of laparoscopic RYGB in obese ESRD patients will be assessed.
Measured: 1 year
Secondary outcomes (1)
Weight reduction in ESRD patients will be characterized to assess additive risk factors for micronutrient abnormalities and protein malnutrition.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startOct 2005
- Primary completionJul 2011
- Study completionJul 2011
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanjay Kulkarni, Yale University
- Investigators
- Sanjay Kulkarni, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580762
- Sponsor's protocol ID
- 0508000519
- Status last verified
- Sep 2016
- First submitted
- 18 Dec 2007
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obesity, End-Stage Renal Disease and Kidney Transplantation
- ClinicalTrials.gov ID
- NCT00580762
- Acronym / sponsor ID
- 0508000519
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESRD | Experimental | Procedure: Roux-en-y gastric bypass (RYGB)End-Stage Renal Disease (ESRD) patients on dialysis who meet the NIH guidelines and preoperative requirements for RYGB will undergo laparoscopic RYGB |
| Non-ESRD | Active comparator | Procedure: Roux-en-y gastric bypass (RYGB)Non-ESRD patients who meet the NIH guidelines and preoperative requirements for RYGB will undergo laparoscopic RYGB |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Roux-en-y gastric bypass (RYGB) | Procedure or surgery | ESRD, Non-ESRD |
Primary outcome
The safety and efficacy of laparoscopic RYGB in obese ESRD patients will be assessed.
Time frame: 1 year
1 secondary outcome
Weight reduction in ESRD patients will be characterized to assess additive risk factors for micronutrient abnormalities and protein malnutrition.
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Kulkarni, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Roux-en-y gastric bypass (RYGB) in people with Obesity and ESRD, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety and efficacy of laparoscopic RYGB in obese ESRD patients will be assessed. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2016.