Bariatric Artery Embolization for Fatty Liver Disease

Overseen By Keith Pereira, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Keith Pereira, MD:

Must not be taking: Anticoagulants, Aspirin, NSAIDs, Hepatotoxic drugs

Disqualifiers: Pregnancy, Substance abuse, Psychiatric problems, Alcohol consumption, Diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

8 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking aspirin and NSAIDs (non-steroidal anti-inflammatory drugs) for at least 3 days before and 30 days after the procedure. If you are on anticoagulant medications and radial access cannot be obtained, you may be excluded from the trial. Additionally, if you are taking certain anti-diabetic medications or hepatotoxic drugs, you may not be eligible to participate.

Is Bariatric Artery Embolization safe for treating fatty liver disease?

The research articles provided do not contain specific safety data for Bariatric Artery Embolization or Embospheres Microspheres for fatty liver disease or other conditions. ^{1 2 3 4 5}

How is the treatment Embospheres Microspheres unique for fatty liver disease?

Embospheres Microspheres is a unique treatment for fatty liver disease because it involves a procedure called bariatric artery embolization, which targets blood vessels to reduce blood flow to specific areas, potentially reducing liver fat. This approach is different from standard treatments that typically focus on lifestyle changes or medications to manage liver fat. ^{6 7 8 9 10}

What is the purpose of this trial?

Obesity is an epidemic in the US. With progression of obesity, Nonalcoholic steatohepatitis (NASH) has been a growing public health issue. Presently there is no cure for NASH.Prevention of progression of fibrosis in NASH is crucial, as they are at a high risk for cirrhosis and may need liver transplant. Recent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and result in weight loss.The purpose of this study is to determine if Left gastric artery embolization (LGAE) in patients with obesity and NASH leads to clinically significant weight loss with improvement of NASH.

Research Team

Kirubahara Vaheesan, MD

Principal Investigator

Assistant professor of radiology- Interventional radiology

Keith Pereira, MD

Principal Investigator

Assistant professor of radiology-Interventional radiology

Brent Neuschwander-Tetri, MD

Principal Investigator

Professor of medicine- gastroenterology

Eligibility Criteria

This trial is for adults aged 22 or older with obesity (BMI >35 kg/m2) and diagnosed with NASH, who haven't succeeded in losing weight through diet, exercise, or behavior modification. They should have tried other weight loss methods without success and have a liver biopsy confirming NASH within the last year. Participants need to be mentally fit to consent and follow study procedures.

Inclusion Criteria

My liver is working well, with bilirubin levels below 3 mg/dL.

Elevated alanine or aspartate aminotransferase values (ALT >41 or AST>34 U/L)

I am willing and able to follow the study rules and will be available for its duration.

Exclusion Criteria

My cancer has spread to other parts of my body.

I have had a procedure to block blood flow to certain organs.

Abnormal Nuclear Gastric Motility examination

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Left Gastric Artery Embolization (LGAE) to promote weight loss and improve NASH

12 months

Regular follow-up visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including weight loss and changes in liver histology

12 months

Regular follow-up visits as per protocol

Treatment Details

Interventions

• Embospheres Microspheres

Trial Overview The trial tests if blocking blood vessels leading to the stomach using Embospheres Microspheres can reduce appetite hormone levels, cause significant weight loss, and improve conditions of NASH in obese patients.

Participant Groups

Group I: NASH- Left gastric artery embolization Experimental Treatment 1 Intervention

Embospheres Microspheres as artificial embolic agent for left gastric artery embolization

Who Is Running the Clinical Trial?

Keith Pereira, MD:

Lead Sponsor

Trials

1

Recruited

8+

Findings from Research

In a meta-analysis of 41 randomized controlled trials involving 2,944 participants with non-alcoholic steatohepatitis (NASH), 68% of those on placebo experienced at least one adverse event (AE), highlighting the need for careful safety evaluations in this largely asymptomatic condition.

Serious adverse events were reported in 7.8% of placebo participants, with a notably higher incidence in phase 3 trials and those funded by pharmaceutical companies, indicating that the context of the study may influence safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo Adverse Events in Non-alcoholic Steatohepatitis Clinical Trials: A Pooled Analysis of 2,944 Participants. Tay, PWL., Ng, CH., Lin, SY., et al.[2023]

Current treatments for nonalcoholic fatty liver disease (NAFLD) are still not very effective, but weight loss remains a key target for therapy despite being difficult to achieve.

Several investigational drugs show promise for treating NASH, but concerns about long-term safety exist, particularly with vitamin E and other medications like pioglitazone and obeticholic acid, which have notable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment options for nonalcoholic steatohepatitis - a safety evaluation. Issa, D., Wattacheril, J., Sanyal, AJ.[2017]

In a review of 15 randomized controlled trials involving both adults and children, metformin showed a significant effect on normalizing alanine transaminase levels compared to vitamin E, indicating its potential efficacy in treating nonalcoholic fatty liver disease (NAFLD).

While some treatments like pioglitazone showed reduced liver necrosis and inflammation, the overall limited data and methodological issues in the studies prevent definitive conclusions about the efficacy of various pharmacological and dietary interventions for NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological interventions for nonalcoholic fatty liver disease in adults and in children: a systematic review. Socha, P., Horvath, A., Vajro, P., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Placebo Adverse Events in Non-alcoholic Steatohepatitis Clinical Trials: A Pooled Analysis of 2,944 Participants. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Treatment options for nonalcoholic steatohepatitis - a safety evaluation. [2017]

3. England pubmed.ncbi.nlm.nih.gov

Nonalcoholic fatty liver disease and mortality from all causes, cardiovascular disease, and cancer: a meta-analysis. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Association of changes in body mass index and waist circumference with cardiovascular risk in non-alcoholic fatty liver disease: A nationwide study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Pharmacological interventions for nonalcoholic fatty liver disease in adults and in children: a systematic review. [2022]

6. Ireland pubmed.ncbi.nlm.nih.gov

Fat embolism. [2019]

7. Brazil pubmed.ncbi.nlm.nih.gov

Fat embolism in liposuction and intramuscular grafts in rabbits. [2019]

8. South Africa pubmed.ncbi.nlm.nih.gov

Fat embolism in kwashiorkor. [2014]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Fat embolism syndrome with neurological involvement: A case report. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Fat embolism in infancy after intravenous fat infusions. [2019]