PROMETEO-HG
Key facts
- Where
- Córdoba, Málaga, Sevilla és Tarragona, SpanyolországSee the 5 sites
- Phase
- 3. fázis
Where in Spanyolország
- Hospital Universitario Reina SofiaCórdoba, SpanyolországTaking people
- Hospital Universitario Regional de MálagaMálaga, SpanyolországTaking people
- Hospital Universitario Virgen de la VictoriaMálaga, SpanyolországTaking people
- University Hospital Virgen Del Rocio S.L.Sevilla, SpanyolországTaking people
- Hospital Universitari Joan XXIII de TarragonaTarragona, SpanyolországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Consorcio Centro De Investigacion Biomedica En Red
- Trial code
- EU 2024-516561-37-01
- Record updated
- 2024. december 19.
- Original description
To determine which of the three models of therapeutic intervention induces a greater sustained regression of fatty liver associated with long-term metabolic disease (18 months) measured by non-invasive techniques (MRI) in patients with Metabolic Associated Fatty Liver Disease and prediabetes.Read full original descriptionShow less
Control strategies and pharmacogenetic study for the personalized treatment of fatty liver associated with metabolic dysfunction in patients with prediabetes.
To determine which of the three models of therapeutic intervention induces a greater sustained regression of fatty liver associated with long-term metabolic disease (18 months) measured by non-invasive techniques (MRI) in patients with Metabolic Associated Fatty Liver Disease and prediabetes.
Inclusion: 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).
Exclusion: 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; 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; 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); Sexually active men with a woman of childbearing age who plans to become pregnant; 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.