2024-519774-40-00招募中4 期
Effect of Mediterranean diet combined with intermittent fasting on liver fibrosis compared to naltrexone/bupropion (Mysimba) in people with cardiometabolic risk factors
Sint Franciscus Vlietland Groep Stichting1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年1月30日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Between-group difference in liver fibrosis during six months. Liver fibrosis will be measured as liver stiffness (kPa) by transient elastography (TE) (FibroScan®)
研究概览
简要总结
To determine the difference in effectiveness of an early time restricted eating Mediterranean diet (eTRE-MD) during six months of intervention on improvement of liver fibrosis when compared to Mysimba in individuals with one or more cardiometabolic risk factor(s) and moderate to severe liver fibrosis (LSM >7.0 kPa by Fibroscan).
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
- •BMI > 27 kg/m2 and at least one cardiometabolic risk factor (type 2 diabetes, hypertension, dyslipidaemia) or BMI > 30
- •Moderate to severe liver fibrosis (LSM >7.0 kPa and <13.6 kPa)
- •Aged 18-75 years
- •Written informed consent
排除标准
- •An insufficient comprehension of the Dutch language (spoken and written)
- •Participants using GLP-1 agonists for less than 3 months or not yet on a stable dose
- •Known or suspected excessive alcohol consumption (>21 drinks/week for males or >14 drinks/week for females. One drink is equivalent to 10 grams of alcohol)
- •Previous or planned (during the trial period) obesity treatment with surgery. However, previous interventions that, due to reversal or removal, do not have any influence on the patient’s weight, in the opinion of the investigator, are allowed
- •Participants with a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the investigator, may compromise the patient’s safety or ability to complete the study
- •Female who is pregnant, breast-feeding or intends to become pregnant
- •Participants with an established diagnosis of liver pathology like, but not limited to: Hepatitis B, Hepatitis C, Autoimmune hepatitis, Wilson’s disease, Hemochromatosis, Primary biliary cholangitis, Primary sclerosing cholangitis, Alcoholic liver disease
- •History of liver transplant, or current placement on a liver transplant list
- •History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy or variceal bleeding
- •Participants with active HIV infection and/or treatment
- •Participants with diagnosed malignancies with or without active treatment
- •Participants with history or pre-existing renal disease (eGFR <30 mL/min/1.73 m2)
- •Participants with corticosteroid induced diabetes (while still using corticosteroids)
结局指标
主要结局
Between-group difference in liver fibrosis during six months. Liver fibrosis will be measured as liver stiffness (kPa) by transient elastography (TE) (FibroScan®)
Between-group difference in liver fibrosis during six months. Liver fibrosis will be measured as liver stiffness (kPa) by transient elastography (TE) (FibroScan®)
次要结局
- Liver steatosis (CAP score, FibroScan)
- Nutritional assessment: Body weight (kg), height (cm), waist circumference (cm), fat mass and lean body mass measured with bioelectrical impedance analysis (kg), grip strength (kg)
- Cardiovascular risk factors: total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, apolipoprotein B (ApoB), apolipoprotein AI (ApoAI), lipoprotein (a), HbA1c, fasting blood glucose, fasting insulin and blood pressure, measured with routine lab procedures
- Other laboratory measurements, measured with routine lab procedures. Among others the following routine measurements will be done: creatinine, estimated GFR (eGFR), alanine aminotransferase (ALAT), aspartate aminotransferase (ASAT), thrombocytes, haemoglobin (Hb), leukocytes, transferrin and ferritin, total iron binding capacity, apolipoprotein B48 (ApoB48), fibroblast growth factor 19 (FGF19) and 21 (FGF21), C-reactive protein (CRP), fibrosis-4 index score (Fib-4)
- Physical activity
- Quality of life
- Patient satisfaction
- Food intake and adherence to the dietary intervention
- Demographic variables, drug use, smoking and drinking habits, (diabetes) medication use and compliance to the time restriction
研究者
Carmen Dietvorst
Scientific
Sint Franciscus Vlietland Groep Stichting
研究点 (1)
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