Gastric Bypass + Kidney Transplant for Obesity and Kidney Failure
SD
Overseen BySheri Dixon, RN BSN
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Vanderbilt University Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
What You Need to Know Before You Apply
What is the purpose of this trial?
Gastric Bypass followed by renal transplantation is superior to medical management followed by renal transplant for patients with severe obesity and renal failure.
Who Is on the Research Team?
SK
Seth Karp, MD
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
I am younger than 60 years old.
Adequate insurance
You have someone who can support you during the study.
See 2 more
Exclusion Criteria
I have Crohn's disease.
I have had weight loss surgery in the past.
I have had surgery to prevent acid reflux.
See 13 more
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo either medical weight loss management or surgical gastric bypass followed by renal transplantation
18 months
Follow-up
Participants are monitored for safety, effectiveness, and various health outcomes including nutritional status, weight loss, and comorbidities
5 years
What Are the Treatments Tested in This Trial?
Interventions
- Gastric Bypass
Trial Overview 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.
How Is the Trial Designed?
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
Trials
922
Recruited
939,000+
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