AzTrials
AzTrials

Hepatitis B, ChronicFitLiverNCT05265026

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

A study testing High Intensity Interval Training in people with Hepatitis B, Chronic and Hepatic Steatosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Hepatitis B, Chronic, Hepatic Steatosis
What is being tested?
High Intensity Interval Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteDenmark
Study dates
14 Mar 2022to 1 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • HIV, HCV, HDV-co infection
  • Primary biliary cholangitis
  • Wilsons Disease
  • Autoimmune hepatitis
  • Hepatocellular carcinoma
  • Antiviral medication
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Centre for Physical Activity Research

    Copenhagen

Other trials in Denmark

About this study

Official 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

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.

Read the detailed description

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.

Being tested
High Intensity Interval Training
Medical subject headings
Hepatitis B, Chronic, Fatty Liver

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Intensity Interval TrainingBehavioural

    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).

Study groups in NCT05265026
Study groupRoleWhat they receive
Exercise Intervention ArmExperimentalThree high intensity interval exercise sessions per week of 40 minutes duration per session. Exercise will be performed on ergometerbikes.
Receives: Behavioral: High Intensity Interval Training
No InterventionNo interventionNo lifestyle changes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fat-Fraction of the Liver

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

    Measured: From baseline to follow-up at 12 weeks

Secondary outcomes (31)

  1. Fibroblast growth factor 21 (FGF21) secretion

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

    Measured: From baseline to follow-up at 12 weeks

  2. Follistatin secretion

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

    Measured: From baseline to follow-up at 12 weeks

  3. Growth/differentiation factor 15 (GDF15) secretion

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

    Measured: From baseline to follow-up at 12 weeks

  4. Angiopoietin-like 4 (ANGPTL4) secretion

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

    Measured: From baseline to follow-up at 12 weeks

  5. C-reactive protein (CRP) secretion

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

    Measured: From baseline to follow-up at 12 weeks

  6. Interferon-ϒ secretion

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

    Measured: From baseline to follow-up at 12 weeks

  7. Interleukin-10 secretion

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

    Measured: From baseline to follow-up at 12 weeks

  8. Interleukin-8 secretion

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

    Measured: From baseline to follow-up at 12 weeks

  9. Interleukin-6 secretion

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

    Measured: From baseline to follow-up at 12 weeks

  10. Interleukin-1 secretion

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

    Measured: From baseline to follow-up at 12 weeks

  11. TNFα secretion

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

    Measured: From baseline to follow-up at 12 weeks

  12. Visceral fat

    Visceral fat assessed by MRI (kg)

    Measured: From baseline to follow-up at 12 weeks

  13. Total fat mass

    Total fat mass assessed by DXA scan (kg)

    Measured: From baseline to follow-up at 12 weeks

  14. Total free fat mass

    Total free fat mass assessed by DXA scan (kg)

    Measured: From baseline to follow-up at 12 weeks

  15. Total lean body mass

    Total lean body mass assessed by DXA scan (kg)

    Measured: From baseline to follow-up at 12 weeks

  16. Body weight

    Body weight (kg)

    Measured: From baseline to follow-up at 12 weeks

  17. Blood pressure measurements

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

    Measured: From baseline to follow-up at 12 weeks

  18. Physical fitness (VO2max)

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

    Measured: From baseline to follow-up at 12 weeks

  19. Total physical activity

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

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

  20. Moderate and vigorous physical activity (MVPA)

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

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

  21. Sedentary time (SED)

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

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

  22. Hepatitis B virus (DNA)

    Hepatitis B virus (DNA) (IU/mL)

    Measured: From baseline to follow-up at 12 weeks

  23. Oral glucose tolerance test

    Oral glucose tolerance test (mmol/L)

    Measured: From baseline to follow-up at 12 weeks

  24. Glycated haemoglobin type 1AC (HbA1c)

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

    Measured: From baseline to follow-up at 12 weeks

  25. Fasting glucose

    Fasting glucose (mmol/L)

    Measured: From baseline to follow-up at 12 weeks

  26. Fasting Insulin

    Fasting Insulin (pmol/L)

    Measured: From baseline to follow-up at 12 weeks

  27. Lipid measurements

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

    Measured: From baseline to follow-up at 12 weeks

  28. Alanine transaminase (ALT)

    Alanine transaminase (ALT) (U/L)

    Measured: From baseline to follow-up at 12 weeks

  29. Aspartate transaminase (AST)

    Aspartate transaminase (AST) (U/L)

    Measured: From baseline to follow-up at 12 weeks

  30. Fibrosis-4 (FIB-4)

    Fibrosis-4 (FIB-4)

    Measured: From baseline to follow-up at 12 weeks

  31. International Normalised Ratio (INR)

    International Normalised Ratio (INR)

    Measured: From baseline to follow-up at 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2022
  2. Study start14 Mar 2022
  3. Primary completion30 Sep 2023
  4. Study completion1 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05265026
Sponsor's protocol ID
H-21034236
Acronym
FitLiver
Status last verified
Oct 2023
First submitted
11 Feb 2022
Last updated
27 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: If the data can be fully anonymized then the data can be shared.

Publications

  • Jespersen S, Plomgaard P, Madsbad S, Hansen AE, Bandholm T, Pedersen BK, Ritz C, Weis N, Krogh-Madsen R. Effect of aerobic exercise training on the fat fraction of the liver in persons with chronic hepatitis B and hepatic steatosis: Trial protocol for a randomized controlled intervention trial- The FitLiver study. Trials. 2023 Jun 13;24(1):398. doi: 10.1186/s13063-023-07385-y.

    PubMed 37312098

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Interval Training in people with Hepatitis B, Chronic and Hepatic Steatosis, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fat-Fraction of the Liver (time frame: From baseline to follow-up at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05265026, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in