According to the National Institute of Health, fatty liver disease is a condition in which fat builds up in the liver. Certain health conditions, such as type 2 diabetes can make one more likely to develop fatty liver disease. Fatty liver disease often has no symptoms and is usually found when abnormal liver enzyme levels are seen during routine lab work.
Fatty liver is a common disorder that is increasing in prevalence worldwide. It is estimated that one out of five people in the US and worldwide have fatty liver disease. However, the prevalence of fatty liver in people who are obese and have type 2 diabetes has been estimated to be above 70%.
No medications have been approved to treat fatty liver disease. This study is to evaluate the effect of the investigational medication for this study, also called the study drug, in people who have both fatty liver disease and type 2 diabetes or pre-diabetes.
Since fatty liver disease can affect so many people and has no approved treatment, it is important that research is conducted to continue to advance medical knowledge about potential treatments. Conducting such research depends on volunteer participants. This is why we hope you will provide us with your contact information to learn more about participating.
If you provide us with your contact information, we will promptly reach out to you to provide you with more information about the study. You can decide if joining the study is right for you.
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To participate in this research study, patients must: |
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*be an adult age 18 to 65 |
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*have type 2 diabetes or pre-diabetes |
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*have fatty liver disease |
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Additional requirements to join will apply. These requirements will be discussed with you by the study staff if you are interested in proceeding with the study.
While participation in a clinical trial, also called a research study, is voluntary, you may be compensated for your time and travel expenses. Up to $4,300 may be available. Compensation will be discussed with you by the staff at the research clinic.
Are you interested in participating or do you just wish to learn more? Please provide us with your contact information. We will contact you within two business days.
Doctors and scientists are constantly finding new drugs that may help prevent, detect, diagnose, control, and treat illnesses. A clinical trial or research study is a scientific study that tests these new discoveries. Research studies depend upon the participation of volunteers.
There is no guarantee that subjects will receive any benefit from being in the study. The study drug may work only as well or even not as well as existing approved medications. However, this research study may yield new information that could benefit people with fatty liver disease and type 2 diabetes or pre-diabetes in the future by helping to answer questions about the efficacy and safety of the study drug.
Participation in a research study is completely voluntary. In all research studies, qualified potential participants are first told about the research study in detail. After receiving this information, all participants must give their consent in writing to proceed. Some research studies involve more tests and doctor visits than the participant would normally have for an illness or condition.
Health Insurance is NOT required to participate.
There are no charges for you for to participate in this medical research study. You will not be charged for the study drug, study-related procedures and tests, or study visits.
Before joining a research study, volunteers must meet specific requirements. These requirements are based on various factors. These can include your age, medical history, current health status, current medications, and drug allergies. The list of things that must be satisfied before a person can participate in a research study are called Inclusion Criteria. The list of things that will stop a person from participating in a research study are called Exclusion Criteria. The Inclusion and Exclusion Criteria were developed to help make the results of the study accurate. They were also developed for the safety of all participants. We will not know whether you satisfy all study requirements until we speak with you and, if needed, complete a screening assessment at our facilities.
The Texas Liver Institute's vision is to lead scientific advancements in understanding liver diseases, developing treatments, and raising global awareness through education. The Institute sets the standard of excellence in liver disease care, providing for our patients' well-being, alleviating suffering, and inspiring hope through access to the most promising new treatments available today.
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