About this trial
Nonalcoholic steatohepatitis (NASH) is the aggressive form of nonalcoholic fatty liver disease, which is rapidly becoming a worldwide public health problem. It is more common in the military and Veteran population compared to the general US population. NASH may progress to end-stage liver disease and primary liver cancer, and hence there is critical need for effective treatment. The goal of this clinical trial is to test whether low dose thyroid hormone administered to Veterans diagnosed with NASH can be an effective therapy mediated by improvement in breaking down fat in the mitochondria. The study will be conducted in two stages, the first stage is for proof of concept to be followed by interim analysis. If the interim analysis supports the merit for continuing the study, the clinical trial will proceed to stage 2 for continuation. This study will provide new information and strategies for treatment of NASH using low dose thyroid hormone that will be highly relevant and impactful to the health of the Veteran population.
Eligibility criteria
Qualifiers
Men and women (pre- and post-menopausal)
Overweight/obese subjects with body mass index (BMI) at or above 25.9 kg/m2
Alcohol intake < 20 grams per day
Patients with type 2 diabetes on stable doses of antidiabetic medication for at least 3 months before enrollment
Disqualifiers
Other causes of hepatitis including hepatitis B & C, autoimmune hepatitis, hemochromatosis, celiac disease, Wilson's disease, alpha-1-antitrypsin deficiency, medication-induced hepatitis
Alcohol consumption of 20 g/d or more
Patients with cirrhosis, bilirubin of 1.3 mg/dL or more, and INR of 1.3 or more
Evidence of Portal hypertension
Trial design
Treatments tested in this trial
- Synthroid
- Placebo
Treatment groups
Locations
1Sponsors and collaborators
VA Office of Research and Development
Lead sponsor