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Vigabatrin for Insulin Resistance
Study Summary
This trial will study whether an existing drug used to treat seizures can also help treat nonalcoholic fatty liver disease, a common complication of obesity.
- Obesity
- Non-alcoholic Fatty Liver Disease
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 2 & 3 trial • 207 Patients • NCT01281202Trial Design
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- Your HOMA-IR score is higher than 2.5.You are between 25 and 60 years old.You have had weight loss surgery in the past.You have been diagnosed with cancer.You have been diagnosed with polycystic ovary syndrome.You have a serious mental illness, including thoughts of hurting yourself or previous attempts to hurt yourself.You regularly smoke or use tobacco products.You drink more than 3 drinks a day if you're a man, or more than 2 drinks a day if you're a woman.You have existing vision problems that could get worse, like retinopathy or glaucoma.You have low levels of red blood cells, which can lead to severe anemia.You have a history of swelling in your legs that could be a sign of heart problems.Your kidneys are not working well, with a certain level of creatinine clearance.You have a body mass index (BMI) between 30.0 and 49.9.You have peripheral neuropathy already.Your HOMA-IR score is higher than 2.5.You are between 25 and 60 years old.Your liver has too much fat (IHTG content ≥5.6).You exercise for at least 250 minutes per week, such as brisk walking.Your weight has changed by more than 4% in the last 2 months.You have a serious health problem with your organs, like your lungs, kidneys, or heart.
- Group 1: Vigabatrin
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does this research encompass adults aged 25 and over?
"The age parameters for this clinical trial are 18-60, allowing adults from a wide range of ages to be recruited."
For whom is this experiment an appropriate option?
"At present, the trial is searching for 20 applicants between 18 and 60 years of age who meet the following criteria: BMI 30.0-49.9 kg/m2, intramyocellular triglyceride content ≥5.6, Homeostatic Model of Insulin Resistance (HOMA-IR) Score>2.5.."
Are there any previously conducted studies involving Vigabatrin?
"Currently, there are 7 ongoing trials exploring Vigabatrin's efficacy. Two of those experiments have already advanced to the Phase 3 stage. Birmingham, Alabama is hosting most of these studies with a total of 44 sites across the country contributing data collection efforts."
What is the scope of participants in this research initiative?
"Affirmative. According to the clinicaltrials.gov database, this trial is currently recruiting participants - it was initially posted on August 23rd 2021 and recently updated on April 11th 2022. 20 patients must be sourced from a single medical site for participation in this study."
Is Vigabatrin sanctioned by the Food and Drug Administration for use?
"Vigabatrin's safety is believed to be satisfactory, as evidenced by its rating of 2. This assessment reflects the fact that there are data points attesting to its security profile but none verifying efficacy."
Are additional participants being accepted for the trial at this time?
"Affirmative. According to the details on clinicaltrials.gov, this medical trial is actively enrolling participants after initiation on August 23rd 2021 and being updated as recently as April 11th 2022. 20 patients are required from a single primary site for participation in this study."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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