Weight Loss Surgery for Fatty Liver Disease

No longer recruiting at 1 trial location
C
Overseen ByCoordinator
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Washington University School of Medicine
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?

This trial explores how weight loss surgery can help people with obesity and fatty liver disease. The main focus is to determine if significant weight loss through surgery can slow liver damage. Suitable candidates for this trial have a body mass index (BMI) of 35 or higher and are already planning to undergo weight loss surgery. As an unphased trial, participants can contribute to important research that may enhance future treatment options.

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.

What prior data suggests that weight loss surgery is safe for people with obesity?

Research has shown that weight loss surgery is generally safe for people with obesity. One study found that patients who underwent this surgery experienced fewer major heart problems and a lower risk of dying from any cause. Another study showed an 88% lower risk of fatty liver disease worsening, such as progressing to cirrhosis or liver cancer, after surgery. Importantly, no major liver-related side effects were reported following the surgery. These findings suggest that weight loss surgery is well-tolerated, especially for those with liver issues related to obesity.12345

Why are researchers excited about this trial?

Weight loss surgery is unique in treating fatty liver disease because it targets the root cause: excess body weight. While existing treatments often focus on lifestyle changes and medications that manage symptoms or slow disease progression, weight loss surgery offers a more direct approach by significantly reducing body mass. Researchers are excited about this treatment because it has the potential to not only alleviate fatty liver disease but also improve overall metabolic health, leading to long-term benefits for patients.

What evidence suggests that weight loss surgery might be an effective treatment for fatty liver disease?

Studies have shown that weight loss surgery, which participants in this trial will undergo, can greatly improve a fatty liver. It helps people lose significant weight and maintain it long-term. Research indicates that this surgery reduces the risk of fatty liver disease progressing to more serious conditions like liver cirrhosis or cancer by 88%. It also lowers the chance of serious complications by 72%. Thus, weight loss surgery can be a very effective way to improve liver health in people with obesity.23467

Are You a Good Fit for This Trial?

This trial is for individuals with obesity, specifically those who have a body mass index (BMI) of 35 kg/m2 or higher and are scheduled for weight loss surgery. It's not open to pregnant individuals, people with liver diseases other than NAFLD, those who've had bariatric surgery before, anyone with significant organ dysfunction/disease, tobacco users, or heavy alcohol drinkers.

Exclusion Criteria

Tobacco use
Pregnancy
Excessive alcohol use
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Pre-surgery Assessment

Participants undergo various assessments including genotyping, body composition, and insulin sensitivity before weight loss surgery

Up to 6 months

Weight Loss Surgery

Participants undergo weight loss surgery to achieve significant weight loss

1 visit (in-person)

Post-surgery Follow-up

Participants are monitored for changes in liver fibrogenesis, lipid turnover, and other metabolic functions after weight loss

Up to 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Weight loss surgery
Trial Overview The study is looking at how effective significant weight loss from bariatric surgery can be on improving liver health in people with non-alcoholic fatty liver disease (NAFLD). The focus is on the rate of hepatic fibrogenesis reduction post-surgery.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Weight lossExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Citations

Non-Alcoholic Fatty Liver Disease (NAFLD) and Bariatric/ ...The only proven method for NAFLD improvement and resolution is weight loss. Bariatric surgery leads to significant and long-term weight loss as ...
The Effect of Bariatric Surgery on the Spectrum of Fatty ...Specifically, severely obese patients undergoing bariatric surgery demonstrate NAFLD rates as high as 90% [2]. Studies that have evaluated the effect of surgery ...
Outcomes After Bariatric Surgery in Patients With Obesity ...Bariatric surgery was significantly associated with lower risks of major adverse cardiovascular events and all-cause mortality.
New Study Shows Significant Drop in Liver and Heart ...Researchers found bariatric surgery was associated with an 88% lower risk of progression of fatty liver to cirrhosis, liver cancer, or liver- ...
Weight-Loss Surgery Lowers Risk of Developing ...“Bariatric surgery was associated with a 72% lower risk of developing serious complications of liver disease and an 80% lower risk of ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37940737/
Impact of Nonalcoholic Fatty Liver Disease (NAFLD) on ...Our data show that patients' body weight loss in response to bariatric surgery is impacted by factors such as preexisting NAFLD.
The impact of bariatric surgery on liver enzymes in people ...Significant improvements in metabolic outcomes after bariatric surgery, with no significant liver-related adverse outcomes, have been shown even amongst ...
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