Skip to main content
OpenTrials
Completed

NCT Number: NCT05265026

Aerobic Exercise Training in Patients With Chronic Hepatitis B and Hepatic Steatosis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis B, Chronic Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Fatty Liver Hepadnaviridae Infections Hepatic Steatosis Hepatitis Hepatitis B Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Physical Activity Research

Copenhagen, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic hepatitis B defined by HBsAg positive >6 months
  • Positive HBV-DNA
  • Age >30
  • Hepatic steatosis diagnosed by Controlled Attenuated Parameter (CAP) >250 assessed by Transient Elastography or by ultrasound defined hepatic steatosis

Exclusion criteria

  • 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

Treatment and study plan

High Intensity Interval Training

Behavioral

A training session consists of 40 minutes as follows: 4x4 minutes at > 85% of heart rate maximum (HRmax) alternated by 3x3 minutes active recovery at (50-70% of HRmax) and a 10-min-warm-up (60-79% of HRmax) and 5- minute cool-down at ~ warm up intensity. HRmax was determined during the VO2max test at baseline visit. Minutes spent in the different heart rate zones is monitored during the session (zone 1: 60-69%, zone 2: 70-74%, zone 3: 75-79%, zone 4: 80-84%, zone 5: >85% of HRmax).

Primary outcomes

  1. Fat-Fraction of the Liver

    Time frame: From baseline to follow-up at 12 weeks

    Hepatic fat-fraction measured by MRI with IDEAL-IQ (%)

Secondary outcomes

  1. Fibroblast growth factor 21 (FGF21) secretion

    Time frame: From baseline to follow-up at 12 weeks

    FGF21 (ng/L) secretion during a hormone infusion of somatostatin and glucagon

  2. Follistatin secretion

    Time frame: From baseline to follow-up at 12 weeks

    Follistatin (ng/L) secretion during a hormone infusion of somatostatin and glucagon

  3. Growth/differentiation factor 15 (GDF15) secretion

    Time frame: From baseline to follow-up at 12 weeks

    GDF15 (ng/L) secretion during a hormone infusion of somatostatin and glucagon

  4. Angiopoietin-like 4 (ANGPTL4) secretion

    Time frame: From baseline to follow-up at 12 weeks

    ANGPTL4 (μg/L) secretion during a hormone infusion of somatostatin and glucagon

  5. C-reactive protein (CRP) secretion

    Time frame: From baseline to follow-up at 12 weeks

    CRP (mg/L) secretion during a hormone infusion of somatostatin and glucagon

  6. Interferon-ϒ secretion

    Time frame: From baseline to follow-up at 12 weeks

    Interferon-ϒ (pg/mL) secretion during a hormone infusion of somatostatin and glucagon

  7. Interleukin-10 secretion

    Time frame: From baseline to follow-up at 12 weeks

    Interleukin-10 (pg/mL) secretion during a hormone infusion of somatostatin and glucagon

  8. Interleukin-8 secretion

    Time frame: From baseline to follow-up at 12 weeks

    Interleukin-8 (pg/mL) secretion during a hormone infusion of somatostatin and glucagon

  9. Interleukin-6 secretion

    Time frame: From baseline to follow-up at 12 weeks

    Interleukin-6 (pg/mL) secretion during a hormone infusion of somatostatin and glucagon

  10. Interleukin-1 secretion

    Time frame: From baseline to follow-up at 12 weeks

    Interleukin-1 (pg/mL) secretion during a hormone infusion of somatostatin and glucagon

  11. TNFα secretion

    Time frame: From baseline to follow-up at 12 weeks

    TNFα (pg/mL) secretion during a hormone infusion of somatostatin and glucagon

  12. Visceral fat

    Time frame: From baseline to follow-up at 12 weeks

    Visceral fat assessed by MRI (kg)

  13. Total fat mass

    Time frame: From baseline to follow-up at 12 weeks

    Total fat mass assessed by DXA scan (kg)

  14. Total free fat mass

    Time frame: From baseline to follow-up at 12 weeks

    Total free fat mass assessed by DXA scan (kg)

  15. Total lean body mass

    Time frame: From baseline to follow-up at 12 weeks

    Total lean body mass assessed by DXA scan (kg)

  16. Body weight

    Time frame: From baseline to follow-up at 12 weeks

    Body weight (kg)

  17. Blood pressure measurements

    Time frame: From baseline to follow-up at 12 weeks

    Systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)

  18. Physical fitness (VO2max)

    Time frame: From baseline to follow-up at 12 weeks

    Physical fitness assessed by VO2max (mL/kg/min)

  19. Total physical activity

    Time frame: From baseline, at 6 weeks to follow-up at 12 weeks

    Total physical activity assessed by activity monitor (hours, minutes)

  20. Moderate and vigorous physical activity (MVPA)

    Time frame: From baseline, at 6 weeks to follow-up at 12 weeks

    Moderate and vigorous physical activity (MVPA) activity monitor (hours, minutes)

  21. Sedentary time (SED)

    Time frame: From baseline, at 6 weeks to follow-up at 12 weeks

    Sedentary time (SED) activity monitor (hours, minutes)

  22. Hepatitis B virus (DNA)

    Time frame: From baseline to follow-up at 12 weeks

    Hepatitis B virus (DNA) (IU/mL)

  23. Oral glucose tolerance test

    Time frame: From baseline to follow-up at 12 weeks

    Oral glucose tolerance test (mmol/L)

  24. Glycated haemoglobin type 1AC (HbA1c)

    Time frame: From baseline to follow-up at 12 weeks

    Glycated haemoglobin type 1AC (HbA1c) (mmol/mL)

  25. Fasting glucose

    Time frame: From baseline to follow-up at 12 weeks

    Fasting glucose (mmol/L)

  26. Fasting Insulin

    Time frame: From baseline to follow-up at 12 weeks

    Fasting Insulin (pmol/L)

  27. Lipid measurements

    Time frame: From baseline to follow-up at 12 weeks

    Total cholesterol (mmol/L), total triglyceride (mmol/L), low density lipoprotein (LDL) (mmol/L), high density lipoprotein (HDL) (mmol/L)

  28. Alanine transaminase (ALT)

    Time frame: From baseline to follow-up at 12 weeks

    Alanine transaminase (ALT) (U/L)

  29. Aspartate transaminase (AST)

    Time frame: From baseline to follow-up at 12 weeks

    Aspartate transaminase (AST) (U/L)

  30. Fibrosis-4 (FIB-4)

    Time frame: From baseline to follow-up at 12 weeks

    Fibrosis-4 (FIB-4)

  31. International Normalised Ratio (INR)

    Time frame: From baseline to follow-up at 12 weeks

    International Normalised Ratio (INR)

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • Copenhagen University Hospital, Hvidovre

Registry information

Official study title

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

Acronym: FitLiver

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 3, 2022
Registry last updated
Oct 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.