Reducing Non-Alcoholic Steatohepatitis Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in histological activity after 12-month treatment with empagliflozin
研究概览
简要总结
The goal of this clinical trial is to learn if empagliflozin works to treat non-alcoholic steatohepatitis in adults. The objectives are:
Primary Objective To evaluate the change in histological grading and staging of NASH in patients with confirmed non-alcoholic steatohepatitis (NASH) treated with empagliflozin for a duration of 48 weeks.
Secondary Objective To evaluate the change in findings from non-invasive liver elasticity measurements, laboratory tests, and anthropometric assessments after 48 weeks of empagliflozin administration.
Participants will:
Take empagliflozin every day for 12 months. Visit the clinic according to a protocol at weeks: 1, 2, 4, 12, 24, 36, 48 Visits includes checkups and tests (blood count, basic biochemistry, glycosylated hemoglobin, anthropometry, non-invasive liver stiffness measurement).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability and eligibility to provide informed consent.
- •Age between 18 and 75 years at the time of study initiation.
- •Confirmed or excluded diagnosis of type 2 diabetes mellitus (DM2) according to the target group (OGTT test, HbA1c).
- •Diagnosis of NASH confirmed by a central pathologist based on histological evaluation of a liver biopsy performed within 3 months prior to the initiation of the investigational drug. - The evaluation must include determination of the process activity according to the NAFLD Activity Score (NAS).
- •HbA1c value ≤ 80 mmol/mol.
- •For women of childbearing potential, willingness to use at least two adequate methods of contraception.
排除标准
- •Contraindication to liver biopsy.
- •Documented episode of ketoacidosis.
- •Contraindication or hypersensitivity to empagliflozin.
- •Presence of acute or chronic illness that, in the investigator's opinion, could jeopardize the health or safety of the patient.
- •HbA1c value > 80 mmol/mol.
- •Inability to safely discontinue thiazolidinedione (pioglitazone) therapy.
- •Liver disease of other etiologies, including viral hepatitis B and C, autoimmune hepatitis, alpha-1 antitrypsin deficiency, hemochromatosis, Wilson's disease, primary sclerosing cholangitis, primary biliary cholangitis, or liver cirrhosis (Child-Pugh A, B, C) of any etiology.
- •Use of medications or medical procedures that induce liver steatosis or fibrosis.
- •Proven alcohol use exceeding: Men > 30 g/day, Women > 20 g/day.
- •History of acute or chronic pancreatitis.
- •Known dependence on or use of illegal addictive substances.
- •Significant weight gain or loss: +/- 10% in the last three months.
- •Diagnosis of malignant disease (except treated benign or skin tumors) in the last 5 years.
- •Stroke or myocardial infarction in the last 6 months.
- •Clinically significant dyspnea New York hear association (NYHA) grade III or higher.
- •Proven heart failure with a left ventricular ejection fraction below 40%.
- •estimated glomerular filtration rate(eGFR) values lower than 30 ml/min/1.73 m² or creatinine clearance lower than 30 ml/min.
- •Proven diabetic foot syndrome requiring amputation or with an existing defect.
- •Planned pregnancy, ongoing lactation or pregnancy, positive pregnancy test, lack of at least two adequate contraceptive methods in women of childbearing potential.
- •Participation in another interventional study within the last 3 months before study entry.
- •Legal incapacity or reduced ability to perform legal acts.
- •Serving a prison sentence.
研究组 & 干预措施
NASH
Patients with histological proven NASH (either diabetics and non-diabetics).
干预措施: Empagliflozin 10 miligrams (mg) (Drug)
结局指标
主要结局
Change in histological activity after 12-month treatment with empagliflozin
时间窗: 12 months
Non-alcoholic Fatty Liver Disease Activity Score (NAS) change after intervention. The NAS can range from 0 to 8 and is calculated by the sum of scores of steatosis (0-3), lobular inflammation (0-3) and hepatocyte ballooning (0-2). In patients with NAFLD, NAS score of ≥ 5 strongly correlated with a diagnosis of "definite NASH" whereas NAS ≤ 3 correlated with a diagnosis of "not NASH".
次要结局
- Change of liver stiffness(12 months)
- Anthropometry (height)(12 months)
- Change of liver steatosis(12 months)
- Liver functional tests(12 months)
- Anthropometry (BMI)(12 months)
- Lipidogram(12 months)
- Anthropometry (body weight)(12 months)
- Bilirubin level(12 months)
研究者
Petr Hribek
Principal Investigator
Military University Hospital, Prague