EUCTR2021-000152-19-ES进行中（未招募）1 期
Control strategies and pharmacogenetic study for the personalized treatment of fatty liver associated with metabolic dysfunction in patients with prediabetes.
Consorcio Centro de Investigación Biomédica en Red, M.P. (CIBER)0 个研究点目标入组 390 人开始时间: 2022年2月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 390
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients with HGADM according to the clinical criteria of the International Expert Consensus Statement.
- •2. Age from 18 to 75 years.
- •3. Men and postmenopausal women.
- •4. Evidence of significant nonalcoholic fatty liver disease, defined by a proportional attenuation of the intrahepatic signal> 10% observed by magnetic resonance imaging.
- •5. Overweight or obese with BMI 25-40 kg / m2
- •6. 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).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 293
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 97
排除标准
- •1. Patients with a life expectancy that is less than 5 years.
- •2. History of alcohol consumption> 30 g / day in men or> 20 g / day in women for 3 consecutive months in the last year.
- •3. Inability to maintain complete alcohol withdrawal during the study period.
- •4. Patients with decompensated liver cirrhosis or altered liver function (BiT> 2mg / dL, INR> 1.3).
- •5. Treatment with drugs potentially associated with fatty liver disease in the previous 3 months (amiodarone, corticosteroids, methotrexate, tetracyclines, tamoxifen, oral contraceptives).
- •6. 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.
- •7. Being undergoing chemotherapy or radiotherapy treatment.
- •8. Other causes of fatty liver: fasting, hemochromatosis, Wilson's disease, or autoimmune hepatitis.
- •9. Active evidence of HBV or HCV infection.
- •10. Severe heart failure; NYHA functional class III or IV.
- •11. Type 1 and 2 diabetes.
- •12. Taking other antidiabetic drugs.
- •13. 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.
- •14. 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.
- •15. Participants in other clinical trials in the 30 days prior to the start of the study.
- •16. Sexually active men with a woman of childbearing age who plans to become pregnant.
- •17. Patients with limitation to follow the protocol for any reason.
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