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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

Must not have

Prior weight loss surgery

Prior anti-reflux surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am younger than 60 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had weight loss surgery in the past.

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I have had surgery to prevent acid reflux.

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I cannot walk 200 feet on my own.

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My lung function is reduced or I need oxygen support.

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I have had a kidney transplant.

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I am a Jehovah's Witness.

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I have serious heart artery problems.

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I am HIV positive.

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I have cirrhosis.

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I do not speak English.

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I have had a hernia repair using mesh before.

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I have been diagnosed with schizophrenia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

All-cause mortality

Development or regression of diabetes

Development or regression of other comorbidities

+5 more

Other study objectives

Prograf dosing