PROMETEO-HG

Prior treatment

• Taking other antidiabetic drugs.
• Participants in other clinical trials in the 30 days prior to the start of the study.
• Treatment with drugs potentially associated with fatty liver disease in the previous 3 months (amiodarone, corticosteroids, methotrexate, tetracyclines, tamoxifen, oral contraceptives).
• History of hepatocarcinoma or malignancy in the 5 years prior to inclusion in the study, except cervical carcinoma in situ and basal cell carcinoma or cutaneous basal cell carcinoma.
• Being undergoing chemotherapy or radiotherapy treatment.

Other illness

• Severe heart failure; NYHA functional class III or IV.
• Type 1 and 2 diabetes.
• Severe cardiovascular, renal, endocrine, gastrointestinal, or psychiatric comorbidity that, in the opinion of the investigator, may make adherence to treatment or interpretation of results difficult.
• History of alcohol consumption> 30 g / day in men or> 20 g / day in women for 3 consecutive months in the last year.
• Other causes of fatty liver: fasting, hemochromatosis, Wilson's disease, or autoimmune hepatitis.
• Active evidence of HBV or HCV infection

Lab values

• Chronic diseases not related to metabolic disease: severe psychiatric, chronic kidney failure (GFR <45 ml / min), chronic respiratory failure, chronic processes necessary for treatment that can modify glucose metabolism.
• Patients with decompensated liver cirrhosis or altered liver function (BiT> 2mg / dL, INR> 1.3).

Age

• Sexually active men with a woman of childbearing age who plans to become pregnant.

Other

• Patients with a life expectancy that is less than 5 years.
• Patients with limitation to follow the protocol for any reason.
• Inability to maintain complete alcohol withdrawal during the study period.

• Patients with HGADM according to the clinical criteria of the International Expert Consensus Statement.
• Age from 18 to 75 years.
• Men and postmenopausal women.
• Evidence of significant nonalcoholic fatty liver disease, defined by a proportional attenuation of the intrahepatic signal> 10% observed by magnetic resonance imaging.
• Overweight or obese with BMI 25-40 kg / m2
• Presence of Prediabetes according to the ADA criteria (fasting blood glucose 100-125 mg / dl or HbA1c 5.7% -6.4% or blood glucose 140-199 mg / dl at 2 hours after SOG).