An interventional study of High Intensity Interval Training in Hepatitis B, Chronic and Hepatic Steatosis, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2023-10-27.
Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Treatment
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.
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 19 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Three high intensity interval exercise sessions per week of 40 minutes duration per session. Exercise will be performed on ergometerbikes.
Behavioral: High Intensity Interval Training
No lifestyle changes
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).
Fat-Fraction of the Liver
Hepatic fat-fraction measured by MRI with IDEAL-IQ (%)
Time frame: From baseline to follow-up at 12 weeks
Fibroblast growth factor 21 (FGF21) secretion
FGF21 (ng/L) secretion during a hormone infusion of somatostatin and glucagon
Time frame: From baseline to follow-up at 12 weeks
Follistatin secretion
Follistatin (ng/L) secretion during a hormone infusion of somatostatin and glucagon
Time frame: From baseline to follow-up at 12 weeks
Growth/differentiation factor 15 (GDF15) secretion
GDF15 (ng/L) secretion during a hormone infusion of somatostatin and glucagon
Time frame: From baseline to follow-up at 12 weeks
Angiopoietin-like 4 (ANGPTL4) secretion
ANGPTL4 (μg/L) secretion during a hormone infusion of somatostatin and glucagon
Time frame: From baseline to follow-up at 12 weeks
C-reactive protein (CRP) secretion
CRP (mg/L) secretion during a hormone infusion of somatostatin and glucagon
Time frame: From baseline to follow-up at 12 weeks
Interferon-ϒ secretion
Interferon-ϒ (pg/mL) secretion during a hormone infusion of somatostatin and glucagon
Time frame: From baseline to follow-up at 12 weeks
Interleukin-10 secretion
Interleukin-10 (pg/mL) secretion during a hormone infusion of somatostatin and glucagon
Time frame: From baseline to follow-up at 12 weeks
Interleukin-8 secretion
Interleukin-8 (pg/mL) secretion during a hormone infusion of somatostatin and glucagon
Time frame: From baseline to follow-up at 12 weeks
Interleukin-6 secretion
Interleukin-6 (pg/mL) secretion during a hormone infusion of somatostatin and glucagon
Time frame: From baseline to follow-up at 12 weeks
Interleukin-1 secretion
Interleukin-1 (pg/mL) secretion during a hormone infusion of somatostatin and glucagon
Time frame: From baseline to follow-up at 12 weeks
TNFα secretion
TNFα (pg/mL) secretion during a hormone infusion of somatostatin and glucagon
Time frame: From baseline to follow-up at 12 weeks
Visceral fat
Visceral fat assessed by MRI (kg)
Time frame: From baseline to follow-up at 12 weeks
Total fat mass
Total fat mass assessed by DXA scan (kg)
Time frame: From baseline to follow-up at 12 weeks
Total free fat mass
Total free fat mass assessed by DXA scan (kg)
Time frame: From baseline to follow-up at 12 weeks
Total lean body mass
Total lean body mass assessed by DXA scan (kg)
Time frame: From baseline to follow-up at 12 weeks
Body weight
Body weight (kg)
Time frame: From baseline to follow-up at 12 weeks
Blood pressure measurements
Systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)
Time frame: From baseline to follow-up at 12 weeks
Physical fitness (VO2max)
Physical fitness assessed by VO2max (mL/kg/min)
Time frame: From baseline to follow-up at 12 weeks
Total physical activity
Total physical activity assessed by activity monitor (hours, minutes)
Time frame: From baseline, at 6 weeks to follow-up at 12 weeks
Moderate and vigorous physical activity (MVPA)
Moderate and vigorous physical activity (MVPA) activity monitor (hours, minutes)
Time frame: From baseline, at 6 weeks to follow-up at 12 weeks
Sedentary time (SED)
Sedentary time (SED) activity monitor (hours, minutes)
Time frame: From baseline, at 6 weeks to follow-up at 12 weeks
Hepatitis B virus (DNA)
Hepatitis B virus (DNA) (IU/mL)
Time frame: From baseline to follow-up at 12 weeks
Oral glucose tolerance test
Oral glucose tolerance test (mmol/L)
Time frame: From baseline to follow-up at 12 weeks
Glycated haemoglobin type 1AC (HbA1c)
Glycated haemoglobin type 1AC (HbA1c) (mmol/mL)
Time frame: From baseline to follow-up at 12 weeks
Fasting glucose
Fasting glucose (mmol/L)
Time frame: From baseline to follow-up at 12 weeks
Fasting Insulin
Fasting Insulin (pmol/L)
Time frame: From baseline to follow-up at 12 weeks
Lipid measurements
Total cholesterol (mmol/L), total triglyceride (mmol/L), low density lipoprotein (LDL) (mmol/L), high density lipoprotein (HDL) (mmol/L)
Time frame: From baseline to follow-up at 12 weeks
Alanine transaminase (ALT)
Alanine transaminase (ALT) (U/L)
Time frame: From baseline to follow-up at 12 weeks
Aspartate transaminase (AST)
Aspartate transaminase (AST) (U/L)
Time frame: From baseline to follow-up at 12 weeks
Fibrosis-4 (FIB-4)
Fibrosis-4 (FIB-4)
Time frame: From baseline to follow-up at 12 weeks
International Normalised Ratio (INR)
International Normalised Ratio (INR)
Time frame: From baseline to follow-up at 12 weeks
Plan to share: Undecided — If the data can be fully anonymized then the data can be shared.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rigshospitalet, Denmark