← Back to Search

Procedure

Metabolic Surgery for Obesity (FLAMES Trial)

N/A
Waitlist Available
Led By Ali Aminian, MD
Research Sponsored by Ali Aminian
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Is ≥18 and ≤70 years old
Is a candidate for general anesthesia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, 2 years
Awards & highlights

FLAMES Trial Summary

This trial aims to study a condition called Metabolic Dysfunction-Associated Steatohepatitis (MASH), which is a type of liver disease associated with obesity, diabetes, and high cholesterol. The

Who is the study for?
This trial is for individuals with MASLD, a liver condition linked to obesity and diabetes. It's open to those who have evidence of liver fibrosis (stages F1-F4). Participants must consent to a liver biopsy if they haven't had one recently.Check my eligibility
What is being tested?
The study compares metabolic surgery against medical treatments using incretin-based therapies for MASH. About 120 patients will be randomly assigned to either the surgery or medication group and tracked over two years, including repeat liver biopsies.See study design
What are the potential side effects?
Potential side effects from metabolic surgery can include nutritional deficiencies, gastrointestinal issues, and surgical complications. Incretin-based therapies may cause digestive problems like nausea or vomiting, pancreatitis risk increase, and possible allergic reactions.

FLAMES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 70 years old.
Select...
I am fit for general anesthesia.
Select...
I qualify for weight loss surgery according to 2022 guidelines.
Select...
My BMI is between 35 and 60.

FLAMES Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improvement of at least 1 fibrosis stage of the Kleiner fibrosis classification and no worsening of MASH in the repeat liver biopsy.
Secondary outcome measures
Average Weight loss percentage
Disease-specific Quality of Life (QoL)
Fibrosis progression in the repeat liver biopsy
+2 more
Other outcome measures
Achieved Weight-loss proportions
BMI change (kg/m^2)
Change in cardiovascular and diabetes medications
+15 more

FLAMES Trial Design

2Treatment groups
Active Control
Group I: Metabolic SurgeryActive Control1 Intervention
FLAMES will examine the class effect (not the specific procedure effect) of metabolic surgery. The study is not intended to compare Roux-en-Y Gastric Bypass (RYGB) vs Sleeve Gastrectomy (SG) head-to-head. RYGB and SG constitute one group as a metabolic surgery group. Assignment of RYGB or SG is not based on a randomized design. Each patient and surgical team will make a shared decision about the most appropriate surgical procedure.
Group II: Incretin-Based TherapyActive Control1 Intervention
Three incretin-based medications that have been approved for treatment of obesity including liraglutide, semaglutide, or tirzepatide will be used in the nonsurgical group. The FLAMES will examine the class effect (not the specific drug effect) of incretin-based therapies. The study is not intended to compare semaglutide vs tirzepatide vs liraglutide head-to-head.

Find a Location

Who is running the clinical trial?

Ali AminianLead Sponsor
1 Previous Clinical Trials
3,932 Total Patients Enrolled
1 Trials studying Obesity
3,932 Patients Enrolled for Obesity
Ali Aminian, MDPrincipal InvestigatorThe Cleveland Clinic
1 Previous Clinical Trials
18 Total Patients Enrolled
1 Trials studying Obesity
18 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available slots for patients to participate in this research study?

"According to data available on clinicaltrials.gov, this particular research endeavor is not presently seeking participants. Initially shared on May 1st, 2024, the most recent update was made on April 16th of the same year. Despite this trial being inactive in terms of patient recruitment currently, it's worth noting that there are a substantial number of 1798 other studies actively enrolling subjects at present."

Answered by AI

In how many distinct clinics is this experimental investigation currently being conducted?

"As of now, enrollment is open at 22 diverse sites. These locations include Indore, Turku, and Roma among others. Opting for the nearest site to your residence is crucial in reducing travel obligations post-enrollment."

Answered by AI

Are individuals who are over the age of 80 eligible to participate in this research study?

"Individuals aged between 18 and 70 years old are eligible to participate in this research based on the specified age criteria."

Answered by AI

Who else is applying?

What site did they apply to?
Banner Health Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Fibrosis Lessens After Metabolic Surgery
Ali Aminian 2024. "Fibrosis Lessens After Metabolic Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06374875.
All > Liver Cirrhosis
~80 spots leftby May 2029
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top