Gastric Bypass + Kidney Transplant for Obesity and Kidney Failure

Overseen By Sheri Dixon, RN BSN

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Schizophrenia, Bipolar, Crohn's, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether gastric bypass surgery before a kidney transplant benefits individuals with severe obesity and kidney failure more than losing weight through medical assistance alone. Participants will either undergo gastric bypass surgery or follow a medical weight loss plan. The trial seeks individuals with a body mass index (BMI) between 40 and 55, who have severe obesity and are planning a kidney transplant. As an unphased trial, it offers participants the chance to contribute to important research that could enhance treatment options for others facing similar health challenges.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that gastric bypass surgery is generally safe for people with kidney problems. One study found a slightly higher chance of complications, but they are usually manageable. Another study showed that about 8.8% of participants experienced kidney-related side effects after surgery, yet most saw improvements in kidney function. Importantly, weight loss from the surgery can enhance kidney health over time. Overall, gastric bypass is well-tolerated, and for many patients, the benefits outweigh the risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about combining gastric bypass with kidney transplants for tackling obesity and kidney failure because it offers a dual approach to treating these interlinked conditions. Unlike traditional methods that address either weight loss through lifestyle changes or medication, or kidney failure with dialysis and standalone transplants, this treatment integrates surgical gastric bypass, which significantly aids weight loss and may improve kidney function. The surgical approach not only helps in reducing body mass but also potentially enhances the success and longevity of the kidney transplant. Additionally, the medical weight loss management arm utilizes best practices tailored to individual needs, providing a comprehensive, personalized treatment strategy. This innovative combination could lead to better overall health outcomes for patients struggling with both obesity and kidney failure.

What evidence suggests that gastric bypass might be an effective treatment for obesity and kidney failure?

This trial will compare surgical gastric bypass with medical weight loss management for patients with obesity and kidney failure. Studies have shown that gastric bypass surgery is highly effective for weight loss and can address kidney-related issues such as high blood pressure and diabetes. Research indicates that after 24 months, gastric bypass surpasses the best medical treatments in improving kidney health in certain stages of kidney disease. In teenagers with early kidney problems, kidney health improved following weight-loss surgery. Those who underwent this surgery were 66% less likely to experience a major decline in kidney function compared to those who did not. Additionally, gastric bypass has been linked to improved cholesterol levels, with a 60% chance of resolving cholesterol problems. ^{1 3 6 7 8}

Who Is on the Research Team?

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.

Exclusion Criteria

You are unable to stop smoking.

I have Crohn's disease.

I have had weight loss surgery in the past.

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?

Group I: Surgical Gastric Bypass Experimental Treatment 1 Intervention

Patients will undergo surgical gastric bypass according to standard institutional protocols

Group II: Medical Weight Loss Management Experimental Treatment 1 Intervention

Patients will receive best practices medical management for weight loss under current institutional protocols

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5399773/

Bariatric Surgery and Kidney-Related Outcomes - PMC Bariatric surgery is extremely effective for achieving weight loss and improving CKD risk factors such as hypertension and diabetes.

2. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2766660

Effect of Gastric Bypass vs Best Medical Treatment on Early ... After 24 months, RYGB was more effective than best medical treatment for achieving remission of albuminuria and CKD stage G1 to G-3 and A2 to A- ...

3. kidney-international.org kidney-international.org/article/S0085-2538(16)30564-6/fulltext

Kidney outcomes three years after bariatric surgery in ... Early kidney abnormalities improved following bariatric surgery in adolescents with evidence of preoperative kidney disease.

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1134644/full

Obesity and renal disease: Benefits of bariatric surgery An improvement in dyslipidemia has also been found, with a remission rate of 60% after gastric bypass and 23% after the gastric band (74). The ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4912457/

Bariatric surgery is associated with improvement in kidney ... Results appeared similar if not stronger; individuals who underwent bariatric surgery had a 66% decreased risk of eGFR decline ≥ 30% compared to the non-surgery ...

6. bmcnephrol.biomedcentral.com bmcnephrol.biomedcentral.com/articles/10.1186/s12882-025-04378-8

Kidney outcomes after bariatric surgery: a population-based ... They observed a general tendency of post-surgical CKD improvement with renal adverse events occurring in 8.8% of RYGB patients and 2.3% of SG ...

7. asmbs.org asmbs.org/news_releases/new-study-shows-long-term-effectiveness-of-gastric-bypass-in-treating-type-2-diabetes-and-obesity/

New Study Shows Long-term Effectiveness of Gastric ... Peak weight loss of 31.8% was achieved after 18 months and stabilized at 23% after 10 years and up to the 20-year mark. The overall 15-year ...

8. grandhealthpartners.com grandhealthpartners.com/how-gastric-sleeve-bariatric-surgery-can-lower-your-long-term-risk-of-chronic-kidney-disease-grand-rapids-michigan/

How Gastric Sleeve Bariatric Surgery Can Lower Your ... Chang et al. (2016) found bariatric surgery in severely obese patients reduced kidney function decline and lowered CKD risk. · Friedman et al. ( ...