PIOGLITAZONE for Metabolic-associated fatty liver disease (MAFLD) | Prediabetes

Inclusion criteria

• {"criterion_text":"- Patients with HGADM according to the clinical criteria of the International Expert Consensus Statement.\n- Age from 18 to 75 years.\n- Men and postmenopausal women.\n- Evidence of significant nonalcoholic fatty liver disease, defined by a proportional attenuation of the intrahepatic signal> 10% observed by magnetic resonance imaging.\n- Overweight or obese with BMI 25-40 kg / m2\n- 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)."}

Exclusion criteria

• {"criterion_text":"- Patients with a life expectancy that is less than 5 years.\n- Severe heart failure; NYHA functional class III or IV.\n- Type 1 and 2 diabetes.\n- Taking other antidiabetic drugs.\n- 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.\n- 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.\n- Participants in other clinical trials in the 30 days prior to the start of the study.\n- Sexually active men with a woman of childbearing age who plans to become pregnant.\n- Patients with limitation to follow the protocol for any reason.\n- History of alcohol consumption> 30 g / day in men or> 20 g / day in women for 3 consecutive months in the last year.\n- Inability to maintain complete alcohol withdrawal during the study period.\n- Patients with decompensated liver cirrhosis or altered liver function (BiT> 2mg / dL, INR> 1.3).\n- Treatment with drugs potentially associated with fatty liver disease in the previous 3 months (amiodarone, corticosteroids, methotrexate, tetracyclines, tamoxifen, oral contraceptives).\n- 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.\n- Being undergoing chemotherapy or radiotherapy treatment.\n- Other causes of fatty liver: fasting, hemochromatosis, Wilson's disease, or autoimmune hepatitis.\n- Active evidence of HBV or HCV infection"}

Primary endpoints

• {"endpoint_text":"- Significant decrease in the amount of intrahepatic fat (> 20%) in the absence of liver fibrosis progression.","definition_or_measurement_approach":"Measured by non-invasive techniques (MRI) as stated in the main objective (18 months follow-up)."}

Secondary endpoints

• {"endpoint_text":"- Study of insulin resistance and adipose tissue dysfunction","definition_or_measurement_approach":""}
• {"endpoint_text":"- Search for non-invasive markers of efficacy of the proposed treatments among circulating metabolites (metabolomic and lipidomic methods).","definition_or_measurement_approach":"Use of metabolomic and lipidomic methods to analyse circulating metabolites."}
• {"endpoint_text":"- Study of the intestinal microbiota.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Pharmacogenetic study: influence of genetic variations on the degree of therapeutic response to drugs.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Study of bioimpedanciometry.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Collection of adverse events potentially related to the medication and its administration.","definition_or_measurement_approach":"Collection and recording of adverse events potentially related to medication and administration."}

Spain

Earliest CTIS Part Ii Submission Date

10-12-2024

Latest Decision Or Authorization Date

19-12-2024

Processing Time Days

9

Number Of Sites

6

Number Of Participants

390

Primary sponsor

Full Name

Consorcio Centro De Investigacion Biomedica En Red

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain