Beneficial effects of inorganic nitrates in liver steatosis

Cambridge University Hospitals NHS Foundation Trust0 个研究点目标入组 30 人开始时间: 2017年9月18日最近更新: 2021年11月1日

适应症

试验速览

暂无简介。

•Current participant inclusion criteria (as of 07/02/2018):
•1. Men with clinical diagnosis of non-alcoholic steatohepatitis and a mild (F0-F2) fibrosis stage as predicted by a FIB-4 score < 2.67
•2. Age between 30-55 years
•3. BMI between 25-35
•4. Triglycerides = 1.7 mmol/L
•Previous participant inclusion criteria
•1. Men with clinical diagnosis of non-alcoholic steatohepatitis and a mild (F0-F2) fibrosis stage as predicted by a FIB-4 score < 2.67
•2. Age between 30-55 years
•3. BMI between 25-35
•4. Glycaemia > 5.5 mmol/L
•5. Triglycerides = 1.7 mmol/L

•1. Current participation in other interventional clinical trials (to avoid confounding with other study outcomes), observational studies are allowed
•2. Other hepatic diseases: i.e alcoholic (> 21U/wk), viral and autoimmune hepatitis (AIH, PSC, PBC), genetic conditions (e.g. hemochromatosis), drug-induced hepatitis, etc.
•3. History of chronic conditions that could influence the study outcomes such as
•3.1. Anaemia (Hb< 11g/dL) or abnormal values in WBC, platelet count, or INR
•3.2. Glomerular filtration rate lower than 60 mL/min/1.73m2 or diuretics
•3.3. Active cancer and any diagnosis of malignant cancer in the last 5 years
•3.4. Chronic Inflammatory disease (e.g. IBD, rheumatoid arthritis) in chronic treatment with NSAIDs/Corticosteroids
•3.5. Type 1 diabetes
•4. Treatments that could influence the study outcomes such as:
•4.1. Anti-Diabetic medications (Metformin, TZDs, insulin)
•4.2. Lipid-lowering agents (Fibrates/Omega3)
•4.3. Nitrate-derived agents
•4.4. Anti-acids
•4.5. Beta-blockers
•4.6. Weight loss medications (sibutramine, orlistat, rimonabant) and history of bariatric surgery (weight loss related changes in systemic metabolism)
•4.7. Hormonal therapies (oestrogens, thyroxine, and progesterone)
•4.8. Anti-psychiatric drugs (antidepressants, sedatives, antipsychotics)
•4.9. Sildenafil
•4.10. Anticoagulants

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