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Procedure
Gastric Bypass + Kidney Transplant for Obesity and Kidney Failure
N/A
Waitlist Available
Led By Seth Karp, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age less than 60 years
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial found that for patients with severe obesity and renal failure, gastric bypass followed by renal transplantation was superior to medical management followed by renal transplant.
Who is the study for?
This trial is for individuals under 60 years old with severe obesity and kidney failure, who have a BMI between 40-55 kg/m2, proper insurance, support person availability, and meet all other criteria for kidney transplant. Excluded are those with HIV, significant lung or heart disease, certain psychiatric conditions like schizophrenia or bipolar disorder, Crohn's disease, past surgeries that conflict with the trial procedures or inability to walk short distances.Check my eligibility
What is being tested?
The study is testing if having gastric bypass surgery followed by a kidney transplant provides better outcomes than just medical management before a kidney transplant in patients with severe obesity and renal failure.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with gastric bypass such as nutritional deficiencies, surgical complications like infections or bleeding. Kidney transplantation can also lead to rejection of the organ and infection due to immunosuppressive medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am younger than 60 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ability to reach medical suitability for renal transplant within 18 months after initiating treatment and the change and trajectory of health-related quality of life (HRQOL)
Secondary outcome measures
All-cause mortality
Development or regression of diabetes
Development or regression of other comorbidities
+5 moreOther outcome measures
Prograf dosing
Trial Design
2Treatment groups
Experimental Treatment
Group I: Surgical Gastric BypassExperimental Treatment1 Intervention
Patients will undergo surgical gastric bypass according to standard institutional protocols
Group II: Medical Weight Loss ManagementExperimental Treatment1 Intervention
Patients will receive best practices medical management for weight loss under current institutional protocols
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gastric Bypass
2012
Completed Phase 3
~1810
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
856 Previous Clinical Trials
672,117 Total Patients Enrolled
Seth Karp, MDPrincipal Investigator - Vanderbilt University Medical Center
Vanderbilt University Hospital, Vanderbilt University Medical Center
Harvard Medical Sch (Medical School)
Brigham & Women'S Hospital (Residency)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Crohn's disease.I have had weight loss surgery in the past.I have had surgery to prevent acid reflux.I cannot walk 200 feet on my own.My lung function is reduced or I need oxygen support.You are unable to stop smoking.I have had a kidney transplant.I am younger than 60 years old.I am a Jehovah's Witness.I have serious heart artery problems.You have a problem with drinking alcohol or using drugs.I am HIV positive.You do not follow your dialysis schedule.I have cirrhosis.You have been diagnosed with bipolar disorder.You have someone who can support you during the study.I do not speak English.You meet all the requirements for a kidney transplant.I have had a hernia repair using mesh before.Your body mass index is between 40 and 55.I have been diagnosed with schizophrenia.
Research Study Groups:
This trial has the following groups:- Group 1: Medical Weight Loss Management
- Group 2: Surgical Gastric Bypass
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this research still open to new applicants?
"This research is currently enrolling 75 individuals with severe obesity, aged between 18 and 59 years old. Specifically, prospective participants need to have a body mass index of 40-55 kg/m2 as well as an available support person. Additionally they must meet all the criteria necessary for renal transplantation."
Answered by AI
Is this clinical trial currently recruiting participants?
"According to the most recent information on clinicaltrials.gov, this trial is no longer seeking participants; however, there are still 1,186 other studies recruiting now. The initial post date for this study was April 1st 2014 and its last modification occurred on March 7th 2022."
Answered by AI
Are there age limitations to joining this clinical trial?
"To be eligible for this medical trial, participants must have reached the age of majority and not yet surpassed their 59th birthday."
Answered by AI
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