Effect of Aerobic Exercise Training on Fat-fraction of the Liver in Patients With Chronic Hepatitis B and Hepatic Steatosis: a Randomised Controlled Intervention Trial. The Fit Liver Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Fat-Fraction of the Liver
研究概览
简要总结
This study is a randomised, controlled, unblinded, clinical intervention trial consisting of 12 weeks of aerobic exercise training. Thirty persons with chronic hepatitis B (CHB) and hepatic steatosis are randomised to either aerobic exercise training (intervention group, n=15) or no intervention (control group, n=15). The study will investigate the effects of the exercise intervention on the liver and the hypothesis is that the exercise group will reduce the fat-fraction of the liver after the intervention.
详细描述
Primary aim: To investigate whether regular aerobic exercise training will decrease the fat-fraction of the liver in persons with CHB and hepatic steatosis shown by magnetic resonance imaging (MRI) by use of Iterative Decomposition of water and fat with Echo Asymmetry and Least squares estimation (IDEAL-IQ).
Secondary aim: To investigate the effects of aerobic exercise training on hepatokine secretion in persons with CHB and hepatic steatosis. Also, to investigate if regular physical exercise will improve lipid- and glucose metabolism, liver status, markers of inflammation, body composition, and blood pressure.
Study participants will undergo pre and post the interventioon: Clinical examination with ECG, blood pressure measurements, blood sampling, oral glucose tolerance test, a hormone infusion of somatostatin and glucagon, -increasing the glucagon/insulin ratio mimicking an acute exercise bout, measuring the effect on circulating hepatokines and cytokines, fibroscan, VO2-max test, DXA scan, AX3 activity monitoring, nail fold capillaryscopy, IQOLA SF-36 and IPAQ-SF questionnaire, 24H food intake registration, MRI scan of the liver and optional liver biopsy. 6 and 12 months follow-up is planned.
The exercise intervention will be randomised 1:1 with no stratification: The training program includes three weekly supervised training sessions of 40 minutes/session over 12 weeks. Participants are instructed not to change their lifestyles during the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis B defined by HBsAg positive >6 months
- •Positive HBV-DNA
- •Hepatic steatosis diagnosed by Controlled Attenuated Parameter (CAP) >250 assessed by Transient Elastography or by ultrasound defined hepatic steatosis
排除标准
- •HIV, HCV, HDV-co infection
- •Primary biliary cholangitis
- •Wilsons Disease
- •Autoimmune hepatitis
- •Hepatocellular carcinoma
- •Antiviral medication
- •Steatogenic medication (systemic corticosteroids, amiodarone, tamoxifen, valproic acid, and methotrexate)
- •Average alcohol intake >30 g for men and >20 g for women pr. day
- •Contraindications for MRI scan
- •Coronary artery disease contraindicating HIIT
- •Unable to understand and read written information for participants written consent
- •Pregnancy
结局指标
主要结局
Fat-Fraction of the Liver
时间窗: From baseline to follow-up at 12 weeks
Hepatic fat-fraction measured by MRI with IDEAL-IQ (%)
次要结局
- Follistatin secretion(From baseline to follow-up at 12 weeks)
- Fibroblast growth factor 21 (FGF21) secretion(From baseline to follow-up at 12 weeks)
- Growth/differentiation factor 15 (GDF15) secretion(From baseline to follow-up at 12 weeks)
- Angiopoietin-like 4 (ANGPTL4) secretion(From baseline to follow-up at 12 weeks)
- C-reactive protein (CRP) secretion(From baseline to follow-up at 12 weeks)
- Interleukin-8 secretion(From baseline to follow-up at 12 weeks)
- TNFα secretion(From baseline to follow-up at 12 weeks)
- Visceral fat(From baseline to follow-up at 12 weeks)
- Total fat mass(From baseline to follow-up at 12 weeks)
- Interferon-ϒ secretion(From baseline to follow-up at 12 weeks)
- Interleukin-10 secretion(From baseline to follow-up at 12 weeks)
- Interleukin-6 secretion(From baseline to follow-up at 12 weeks)
- Interleukin-1 secretion(From baseline to follow-up at 12 weeks)
- Total free fat mass(From baseline to follow-up at 12 weeks)
- Total lean body mass(From baseline to follow-up at 12 weeks)
- Physical fitness (VO2max)(From baseline to follow-up at 12 weeks)
- Hepatitis B virus (DNA)(From baseline to follow-up at 12 weeks)
- Fasting glucose(From baseline to follow-up at 12 weeks)
- Body weight(From baseline to follow-up at 12 weeks)
- Blood pressure measurements(From baseline to follow-up at 12 weeks)
- Total physical activity(From baseline, at 6 weeks to follow-up at 12 weeks)
- Moderate and vigorous physical activity (MVPA)(From baseline, at 6 weeks to follow-up at 12 weeks)
- Glycated haemoglobin type 1AC (HbA1c)(From baseline to follow-up at 12 weeks)
- Fasting Insulin(From baseline to follow-up at 12 weeks)
- Lipid measurements(From baseline to follow-up at 12 weeks)
- Alanine transaminase (ALT)(From baseline to follow-up at 12 weeks)
- Fibrosis-4 (FIB-4)(From baseline to follow-up at 12 weeks)
- International Normalised Ratio (INR)(From baseline to follow-up at 12 weeks)
- Sedentary time (SED)(From baseline, at 6 weeks to follow-up at 12 weeks)
- Oral glucose tolerance test(From baseline to follow-up at 12 weeks)
- Aspartate transaminase (AST)(From baseline to follow-up at 12 weeks)
研究者
Sofie Jespersen
Principal Investigator, MD, PhD-student
Rigshospitalet, Denmark