20 Participants Needed

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+
Unbiased ResultsWe believe in providing patients with all the options.
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