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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05265026
Other study ID # H-21034236
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 14, 2022
Est. completion date October 1, 2023

Study information

Verified date October 2023
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date October 1, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years and older
Eligibility 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

Study Design


Intervention

Behavioral:
High Intensity Interval Training
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).

Locations

Country Name City State
Denmark Centre for Physical Activity Research Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
Rigshospitalet, Denmark Copenhagen University Hospital, Hvidovre

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fat-Fraction of the Liver Hepatic fat-fraction measured by MRI with IDEAL-IQ (%) From baseline to follow-up at 12 weeks
Secondary Fibroblast growth factor 21 (FGF21) secretion FGF21 (ng/L) secretion during a hormone infusion of somatostatin and glucagon From baseline to follow-up at 12 weeks
Secondary Follistatin secretion Follistatin (ng/L) secretion during a hormone infusion of somatostatin and glucagon From baseline to follow-up at 12 weeks
Secondary Growth/differentiation factor 15 (GDF15) secretion GDF15 (ng/L) secretion during a hormone infusion of somatostatin and glucagon From baseline to follow-up at 12 weeks
Secondary Angiopoietin-like 4 (ANGPTL4) secretion ANGPTL4 (µg/L) secretion during a hormone infusion of somatostatin and glucagon From baseline to follow-up at 12 weeks
Secondary C-reactive protein (CRP) secretion CRP (mg/L) secretion during a hormone infusion of somatostatin and glucagon From baseline to follow-up at 12 weeks
Secondary Interferon-? secretion Interferon-? (pg/mL) secretion during a hormone infusion of somatostatin and glucagon From baseline to follow-up at 12 weeks
Secondary Interleukin-10 secretion Interleukin-10 (pg/mL) secretion during a hormone infusion of somatostatin and glucagon From baseline to follow-up at 12 weeks
Secondary Interleukin-8 secretion Interleukin-8 (pg/mL) secretion during a hormone infusion of somatostatin and glucagon From baseline to follow-up at 12 weeks
Secondary Interleukin-6 secretion Interleukin-6 (pg/mL) secretion during a hormone infusion of somatostatin and glucagon From baseline to follow-up at 12 weeks
Secondary Interleukin-1 secretion Interleukin-1 (pg/mL) secretion during a hormone infusion of somatostatin and glucagon From baseline to follow-up at 12 weeks
Secondary TNFa secretion TNFa (pg/mL) secretion during a hormone infusion of somatostatin and glucagon From baseline to follow-up at 12 weeks
Secondary Visceral fat Visceral fat assessed by MRI (kg) From baseline to follow-up at 12 weeks
Secondary Total fat mass Total fat mass assessed by DXA scan (kg) From baseline to follow-up at 12 weeks
Secondary Total free fat mass Total free fat mass assessed by DXA scan (kg) From baseline to follow-up at 12 weeks
Secondary Total lean body mass Total lean body mass assessed by DXA scan (kg) From baseline to follow-up at 12 weeks
Secondary Body weight Body weight (kg) From baseline to follow-up at 12 weeks
Secondary Blood pressure measurements Systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) From baseline to follow-up at 12 weeks
Secondary Physical fitness (VO2max) Physical fitness assessed by VO2max (mL/kg/min) From baseline to follow-up at 12 weeks
Secondary Total physical activity Total physical activity assessed by activity monitor (hours, minutes) From baseline, at 6 weeks to follow-up at 12 weeks
Secondary Moderate and vigorous physical activity (MVPA) Moderate and vigorous physical activity (MVPA) activity monitor (hours, minutes) From baseline, at 6 weeks to follow-up at 12 weeks
Secondary Sedentary time (SED) Sedentary time (SED) activity monitor (hours, minutes) From baseline, at 6 weeks to follow-up at 12 weeks
Secondary Hepatitis B virus (DNA) Hepatitis B virus (DNA) (IU/mL) From baseline to follow-up at 12 weeks
Secondary Oral glucose tolerance test Oral glucose tolerance test (mmol/L) From baseline to follow-up at 12 weeks
Secondary Glycated haemoglobin type 1AC (HbA1c) Glycated haemoglobin type 1AC (HbA1c) (mmol/mL) From baseline to follow-up at 12 weeks
Secondary Fasting glucose Fasting glucose (mmol/L) From baseline to follow-up at 12 weeks
Secondary Fasting Insulin Fasting Insulin (pmol/L) From baseline to follow-up at 12 weeks
Secondary Lipid measurements Total cholesterol (mmol/L), total triglyceride (mmol/L), low density lipoprotein (LDL) (mmol/L), high density lipoprotein (HDL) (mmol/L) From baseline to follow-up at 12 weeks
Secondary Alanine transaminase (ALT) Alanine transaminase (ALT) (U/L) From baseline to follow-up at 12 weeks
Secondary Aspartate transaminase (AST) Aspartate transaminase (AST) (U/L) From baseline to follow-up at 12 weeks
Secondary Fibrosis-4 (FIB-4) Fibrosis-4 (FIB-4) From baseline to follow-up at 12 weeks
Secondary International Normalised Ratio (INR) International Normalised Ratio (INR) From baseline to follow-up at 12 weeks
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