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SGLT2 Inhibitors for Non-Alcoholic Fatty Liver Disease
Study Summary
This trial is testing if a certain type of diabetes medication can help treat nonalcoholic fatty liver disease (NAFLD) in obese adolescents.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2019 Phase 2 trial • 80 Patients • NCT03200860Trial Design
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Who is running the clinical trial?
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- My body shows early signs of puberty.My BMI is in the obesity range according to my age and sex.I have urinary or genital issues that increase my risk of infections.I am willing to follow specific lifestyle guidelines during the study.I have been taking medication that can cause weight gain in the last 6 months.My liver enzyme levels are high or I have been diagnosed with fatty liver disease recently.You have a history of drinking a lot of alcohol or currently drink alcohol.My liver enzyme levels have been stable in recent tests.I have tried changing my lifestyle to treat obesity or fatty liver disease.You are confirmed to be obese.I am not pregnant, do not plan to become pregnant, and agree to use effective birth control.I am between 12 and 19 years old.I have liver disease, but it's not due to NAFLD or NASH.My kidney function is reduced.I have had serious liver-related health events.You have a serious mental health condition.I have taken empagliflozin before.I have had cancer in the past.I have used weight loss medication in the last 6 months.I have had weight loss surgery in the past.I am currently taking metformin.I have Gilbert's Syndrome.You are a smoker or use tobacco products.I have a thyroid condition that hasn't been treated.I have been diagnosed with obesity caused by a single gene.I have not had a leg infection or ulcer in the last 3 months.I started taking blood pressure or cholesterol medication less than 3 months ago.My liver is functioning well, not more than 5 times above the normal limit.I have diabetes (type 1 or 2).You have been taking vitamin E supplements.
- Group 1: Control arm
- Group 2: Study intervention
- 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
Has a trial of this kind ever been done before?
"At present, there are 49 active studies regarding Empagliflozin 10 MG being conducted in 43 countries and 237 cities. This drug was first trialled back in 2018 by Boehringer Ingelheim with 175 participants. Since then, a total of 338 trials have been completed; the latest one having reached its Phase 3 stage for official approval."
Does this investigation permit the inclusion of seniors in its population?
"According to the eligibility criteria, individuals aged 12-17 can apply for this study. Currently, there are 40 studies focusing on minors and 378 research opportunities open to those over 65 years of age."
Are there any openings available to join the clinical trial?
"Data on clinicaltrials.gov confirms that this study is actively recruiting participants, having first been posted in May of 2019 and edited most recently October 11th 2022."
What clinical applications are associated with Empagliflozin 10 MG?
"Empagliflozin 10 MG is often prescribed to treat cardiovascular diseases, as well as specific issues like heart failure and type 2 diabetes mellitus. It may even help reduce the risk of cardiovascular mortality."
Who is eligible to join this research endeavor?
"In order to be an eligible candidate for this research, a patient must have liver related pathologies and fall within the 12-17 year age bracket. A total of 40 participants are required for the trial to take place."
How many subjects are currently included in this research endeavor?
"Correct. Records on clinicaltrials.gov demonstrate that this medical research, which was originally posted on May 1st 2019, is actively seeking participants. Approximately 40 individuals need to be recruited from a single site."
Have any other investigations explored the efficacy of Empagliflozin 10 MG?
"Currently, 49 medical trials are underway examining Empagliflozin 10 MG. 13 of those active studies have reached Phase 3 clinical research standards. The main hub for this particular medication is located in Quilmes, Maryland; however, there are over a thousand locations running trials for it across the globe."
Is Empagliflozin 10 MG a safe intervention for patients?
"Our assessment of Empagliflozin 10 MG's safety is 2, given the fact that this drug has only been tested in Phase 2 trials and there is no evidence to prove its efficacy."
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