2024-516561-37-01尚未招募3 期
Control strategies and pharmacogenetic study for the personalized treatment of fatty liver associated with metabolic dysfunction in patients with prediabetes.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 390
- 试验地点
- 5
- 主要终点
- Significant decrease in the amount of intrahepatic fat (> 20%) in the absence of liver fibrosis progression.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •Patients with a life expectancy that is less than 5 years.
- •Severe heart failure; NYHA functional class III or IV.
- •Type 1 and 2 diabetes.
- •Taking other antidiabetic drugs.
- •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.
- •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.
- •Participants in other clinical trials in the 30 days prior to the start of the study.
- •Sexually active men with a woman of childbearing age who plans to become pregnant.
- •Patients with limitation to follow the protocol for any reason.
- •History of alcohol consumption> 30 g / day in men or> 20 g / day in women for 3 consecutive months in the last year.
- •Inability to maintain complete alcohol withdrawal during the study period.
- •Patients with decompensated liver cirrhosis or altered liver function (BiT> 2mg / dL, INR> 1.3).
- •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 causes of fatty liver: fasting, hemochromatosis, Wilson's disease, or autoimmune hepatitis.
- •Active evidence of HBV or HCV infection
结局指标
主要结局
Significant decrease in the amount of intrahepatic fat (> 20%) in the absence of liver fibrosis progression.
Significant decrease in the amount of intrahepatic fat (> 20%) in the absence of liver fibrosis progression.
次要结局
- Study of insulin resistance and adipose tissue dysfunction
- Search for non-invasive markers of efficacy of the proposed treatments among circulating metabolites (metabolomic and lipidomic methods).
- Study of the intestinal microbiota.
- Pharmacogenetic study: influence of genetic variations on the degree of therapeutic response to drugs.
- Study of bioimpedanciometry.
- Collection of adverse events potentially related to the medication and its administration.
研究者
Projects Department
Scientific
Consorcio Centro De Investigacion Biomedica En Red
研究点 (5)
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