Non-alcoholic Fatty Liver DiseaseNCT04882644
Effects of Aerobic Exercise on Lean Non-alcoholic Fatty Liver Disease (NAFLD)
A study testing Aerobic Exercise in people with Non-alcoholic Fatty Liver Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
NAFLD is increasingly being identified in lean individuals, especially in Chinese population. Among the NAFLD patients, the lean NAFLD accounts for 15.9%-23.0%. Previous studies showed that the lean NAFLD individuals might have a higher risk of severe hepatic disease than those obese individuals. Read more about this study
- Who is it for?
- Ages 30 to 55 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 14 May 2021to 30 Sep 2022
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1. Subjects with NAFLD determined by MRI-PDFF (liver fat\>5%).
- 2. Subjects with BMI\<23 kg/m2.
- 3. Subjects with inactive exercise before.
- 4. Subjects with basic abilities of understanding, communication and writing.
Who cannot join
- 1. Regular drinkers (consumed more than an average of 140 grams of ethanol per week in men and 70 grams in women during the past twelve months).
- 2. Complicated with other liver diseases (i.e. acute or chronic viral hepatitis, liver cancer, liver cirrhosis, drug-induced liver diseases, and autoimmune hepatitis).
- 3. Subjects with abnormal liver function (i.e. more than 3 times the upper limit of normal alanine aminotransferase and aspartate aminotransferase).
- 4. Complicated with severe cardiovascular disease [i.e. myocardial infarction, arrhythmia, heart failure (New York Heart Association III or IV), uncontrolled hypertension (i.e. systolic blood pressure \>180 mmHg, and/or diastolic blood pressure \>100 mmHg)].
- 5. Complicated with severe kidney disease or severe renal insufficiency or tumour.
- 6. Currently pregnant or planning to be pregnant or breast feeding women.
Show all 11Show fewer
- 7. Participating in weight loss programs/exercise programs currently or during the past three months.
- 8. Having any medical condition that would affect metabolism or limit exercise (i.e. diabetes, known hyperthyroidism or hypothyroidism).
- 9. Having a medical condition that would limit exercise participation or alter heart rate during exercise or taking medication that would affect metabolism or weight loss (i.e. glucocorticoids, antithyroid drugs, hypoglycemic drugs, antihypertensive drugs).
- 10. Having been doing regular physical exercise for the past three months (i.e. 3 times/week, \>30 min/time).
- 11. Subjects with poor adherence.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital with Nanjing Medical University
Nanjing, China, 210029
About this study
Official title: Effects of Aerobic Exercise on Lean Non-alcoholic Fatty Liver Disease
NAFLD is increasingly being identified in lean individuals, especially in Chinese population. Among the NAFLD patients, the lean NAFLD accounts for 15.9%-23.0%. Previous studies showed that the lean NAFLD individuals might have a higher risk of severe hepatic disease than those obese individuals. However, the effects of aerobic exercise on the reduction of liver fat content and metabolic risk factors in lean NAFLD individuals remain unknown. In this randomized controlled trial, we will examine the effect of a 3-month exercise training (aerobic exercise) on liver fat content and metabolic risk factors in lean NAFLD individuals.
Read the detailed description
The whole study is divided into four phases: recruitment phase, training phase (1 month, aim to gradually adapt patients to the target exercise intensity), implementation phase (3 months), and follow-up phase (9 months). And the subjects are randomly assigned to two groups: aerobic exercise intervention group and control group.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- Aerobic Exercise
- Keywords
- Lean NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic ExerciseBehavioural
The subjects conduct an aerobic exercise at 65-80% maximum oxygen consumption three times per week for 60 min/session (including 5 min warm-up and 5 min cool down) with treadmills, ellipticals, and rowing machine. The subjects attend health education sessions (eg, general health knowledge of NAFLD and metabolic diseases, and elements of a healthy lifestyle) monthly in the 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Aerobic Exercise Intervention Group | Experimental | The subjects receive an intensive aerobic exercise for 3 months and a health education content for 12 months. Receives: Behavioral: Aerobic Exercise |
| Control Group | No intervention | The subjects do not change their physical activity routine and receive a health education content for 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in the liver fat content at 3 months after intervention.
The magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is used to detect the liver content. An diagnosis of NAFLD is the liver fat content > 5%.
Changes = (liver fat content at 3 months after intervention - liver fat content at baseline)
Measured: 3 months
Secondary outcomes (12)
Changes from baseline in body mass index (BMI) at 3/12 months after intervention.
The BMI expressed in units of kg/m2 is calculated as the body weight （kilograms） divided by the square of the body height (meters) while height and weight are measured by calibrated instruments with standard protocols.
Changes = (BMI at 3/12 months after intervention - BMI at baseline).
Measured: 3 months, 12 months
Changes from baseline in waist hip ratio(WHR) at 3/12 months after intervention.
The WHR is calculated as the waist circumference（centimeters）divided by the hip circumference (centimeters) while waist circumference and hip circumference are measured by calibrated instruments with standard protocols.
Changes = (WHR at 3/12 months after intervention - WHR at baseline).
Measured: 3 months, 12 months
Changes from baseline in abdominal fat at 3/12 months after intervention.
Abdominal fat expressed in units of cm2 is detected by MRI-PDFF.
Changes = (the values of abdominal fat at 3/12 months after intervention - the values of abdominal fat at baseline).
Measured: 3 months, 12 months
Changes from baseline in blood pressure at 3/12 months after intervention.
Blood pressure is measured by electronic automated sphygmomanometer.
An normal blood pressure is defined as a systolic blood pressure between 90 and 139 mmHg and a diastolic blood pressure between 60 and 89 mmHg.
Changes = (blood pressure at 3/12 months after intervention - blood pressure at baseline)
Measured: 3 months, 12 months
Changes from baseline in triglycerides at 3/12 months after intervention.
Triglycerides is detected by fasting blood test.
Normal triglycerides level is less than 2.26 mmol/L.
Changes = (triglycerides at 3/12 months after intervention - triglycerides at baseline)
Measured: 3 months, 12 months
Changes from baseline in total cholesterol at 3/12 months after intervention.
Total cholesterol is detected by fasting blood test.
Normal total cholesterol level is less than 5.20 mmol/L.
Changes = (total cholesterol at 3/12 months after intervention - total cholesterol at baseline)
Measured: 3 months, 12 months
Changes from baseline in fasting blood glucose at 3/12 months after intervention.
Fasting blood glucose is detected by fasting blood test.
Normal fasting blood glucose level is a range of 3.90-6.10 mmol/L.
Changes = (fasting blood glucose at 3/12 months after intervention - fasting blood glucose at baseline)
Measured: 3 months, 12 months
Changes from baseline in fasting insulin at 3/12 months after intervention.
Fasting insulin is detected by fasting blood test.
Normal fasting insulin level is a range of 1.8-11.8 μU/mL.
Changes = (fasting insulin at 3/12 months after intervention - fasting insulin at baseline)
Measured: 3 months, 12 months
Changes from baseline in glucose level for oral glucose tolerance test (OGTT) at 3/12 months after intervention.
Participants will fast for at least 10 hours before the test. After a fasting blood sample is drawn, participants will drink 75g glucose in 300 ml water within 3-5 minutes. Blood samples will be drawn at 30 min, 60min and 120 min after glucose loading to measure glucose.
Normal glucose level for OGTT at 2 hours is <7.8 mmol/L.
Changes = (glucose level for OGTT at 2 hours at 3/12 months after intervention - glucose level for OGTT at 2 hours at baseline)
Measured: 3 months, 12 months
Changes from baseline in homeostasis model assessment of insulin resistance (HOMA-IR) at 3/12 months after intervention.
HOMA-IR is calculated as [fasting glucose (mmol/L)* fasting insulin (μU/mL) ] / 22.5.
HOMA-IR < 1 signals optimal insulin sensitivity and HOMA-IR < 2.5 signals normal insulin sensitivity.
Changes = (HOMA-IR at 3/12 months after intervention - HOMA-IR at baseline)
Measured: 3 months, 12 months
Changes from baseline in homeostasis model assessment of β-cell function (HOMA-β) at 3/12 months after intervention.
HOMA-β is calculated as 20 x fasting insulin(μU/ml)/[fasting glucose (mmol/L) - 3.5].
Changes = (HOMA-β at 3/12 months after intervention - HOMA-β at baseline)
Measured: 3 months, 12 months
Changes from baseline in the liver fat content at 12 months after intervention.
The magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is used to detect the liver content. An diagnosis of NAFLD is the liver fat content > 5%.
Changes = (liver fat content at 12 months after intervention - liver fat content at baseline)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start14 May 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 100 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Medical University
- Responsible party
- Principal investigator, Qun Zhang, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Qun Zhang, Professor, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04882644
- Sponsor's protocol ID
- NMU20212022
- Status last verified
- Sep 2024
- First submitted
- 28 Apr 2021
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lee S, Bacha F, Hannon T, Kuk JL, Boesch C, Arslanian S. Effects of aerobic versus resistance exercise without caloric restriction on abdominal fat, intrahepatic lipid, and insulin sensitivity in obese adolescent boys: a randomized, controlled trial. Diabetes. 2012 Nov;61(11):2787-95. doi: 10.2337/db12-0214. Epub 2012 Jun 29.
PubMed 22751691Zhang HJ, He J, Pan LL, Ma ZM, Han CK, Chen CS, Chen Z, Han HW, Chen S, Sun Q, Zhang JF, Li ZB, Yang SY, Li XJ, Li XY. Effects of Moderate and Vigorous Exercise on Nonalcoholic Fatty Liver Disease: A Randomized Clinical Trial. JAMA Intern Med. 2016 Aug 1;176(8):1074-82. doi: 10.1001/jamainternmed.2016.3202.
PubMed 27379904Houghton D, Thoma C, Hallsworth K, Cassidy S, Hardy T, Burt AD, Tiniakos D, Hollingsworth KG, Taylor R, Day CP, McPherson S, Anstee QM, Trenell MI. Exercise Reduces Liver Lipids and Visceral Adiposity in Patients With Nonalcoholic Steatohepatitis in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2017 Jan;15(1):96-102.e3. doi: 10.1016/j.cgh.2016.07.031. Epub 2016 Aug 10.
PubMed 27521509Kistler KD, Brunt EM, Clark JM, Diehl AM, Sallis JF, Schwimmer JB; NASH CRN Research Group. Physical activity recommendations, exercise intensity, and histological severity of nonalcoholic fatty liver disease. Am J Gastroenterol. 2011 Mar;106(3):460-8; quiz 469. doi: 10.1038/ajg.2010.488. Epub 2011 Jan 4.
PubMed 21206486
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise on Lean Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT04882644
- Acronym / sponsor ID
- NMU20212022
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- Lean NAFLD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Nanjing Medical University
- Study start
- 14 May 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
NAFLD is increasingly being identified in lean individuals, especially in Chinese population. Among the NAFLD patients, the lean NAFLD accounts for 15.9%-23.0%. Previous studies showed that the lean NAFLD individuals might have a higher risk of severe hepatic disease than those obese individuals. However, the effects of aerobic exercise on the reduction of liver fat content and metabolic risk factors in lean NAFLD individuals remain unknown. In this randomized controlled trial, we will examine the effect of a 3-month exercise training (aerobic exercise) on liver fat content and metabolic risk factors in lean NAFLD individuals.
Detailed description
The whole study is divided into four phases: recruitment phase, training phase (1 month, aim to gradually adapt patients to the target exercise intensity), implementation phase (3 months), and follow-up phase (9 months). And the subjects are randomly assigned to two groups: aerobic exercise intervention group and control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic Exercise Intervention Group | Experimental | Behavioral: Aerobic ExerciseThe subjects receive an intensive aerobic exercise for 3 months and a health education content for 12 months. |
| Control Group | No intervention | –The subjects do not change their physical activity routine and receive a health education content for 12 months. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 1. Subjects with NAFLD determined by MRI-PDFF (liver fat\&gt;5%).
- 2. Subjects with BMI\&lt;23 kg/m2.
- 3. Subjects with inactive exercise before.
- 4. Subjects with basic abilities of understanding, communication and writing.
Key exclusion criteria (11 listed)
- 1. Regular drinkers (consumed more than an average of 140 grams of ethanol per week in men and 70 grams in women during the past twelve months).
- 2. Complicated with other liver diseases (i.e. acute or chronic viral hepatitis, liver cancer, liver cirrhosis, drug-induced liver diseases, and autoimmune hepatitis).
- 3. Subjects with abnormal liver function (i.e. more than 3 times the upper limit of normal alanine aminotransferase and aspartate aminotransferase).
- 4. Complicated with severe cardiovascular disease [i.e. myocardial infarction, arrhythmia, heart failure (New York Heart Association III or IV), uncontrolled hypertension (i.e. systolic blood pressure \&gt;180 mmHg, and/or diastolic blood pressure \&gt;100 mmHg)].
- 5. Complicated with severe kidney disease or severe renal insufficiency or tumour.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic ExerciseThe subjects conduct an aerobic exercise at 65-80% maximum oxygen consumption three times per week for 60 min/session (including 5 min warm-up and 5 min cool down) with treadmills, ellipticals, and rowing machine. The subjects attend health education sessions (eg, general health knowledge of NAFLD and metabolic diseases, and elements of a healthy lifestyle) monthly in the 12 months. | Behavioural | Aerobic Exercise Intervention Group |
Primary outcome
Changes from baseline in the liver fat content at 3 months after intervention.
Time frame: 3 months
The magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) is used to detect the liver content. An diagnosis of NAFLD is the liver fat content > 5%. Changes = (liver fat content at 3 months after intervention - liver fat content at baseline)
12 secondary outcomes
Changes from baseline in body mass index (BMI) at 3/12 months after intervention.
Time frame: 3 months, 12 months
Changes from baseline in waist hip ratio(WHR) at 3/12 months after intervention.
Time frame: 3 months, 12 months
Changes from baseline in abdominal fat at 3/12 months after intervention.
Time frame: 3 months, 12 months
Changes from baseline in blood pressure at 3/12 months after intervention.
Time frame: 3 months, 12 months
Changes from baseline in triglycerides at 3/12 months after intervention.
Time frame: 3 months, 12 months
Changes from baseline in total cholesterol at 3/12 months after intervention.
Time frame: 3 months, 12 months
Changes from baseline in fasting blood glucose at 3/12 months after intervention.
Time frame: 3 months, 12 months
Changes from baseline in fasting insulin at 3/12 months after intervention.
Time frame: 3 months, 12 months
Changes from baseline in glucose level for oral glucose tolerance test (OGTT) at 3/12 months after intervention.
Time frame: 3 months, 12 months
Changes from baseline in homeostasis model assessment of insulin resistance (HOMA-IR) at 3/12 months after intervention.
Time frame: 3 months, 12 months
Changes from baseline in homeostasis model assessment of β-cell function (HOMA-β) at 3/12 months after intervention.
Time frame: 3 months, 12 months
Changes from baseline in the liver fat content at 12 months after intervention.
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Background: PubMed 22751691Lee S, Bacha F, Hannon T, Kuk JL, Boesch C, Arslanian S. Effects of aerobic versus resistance exercise without caloric restriction on abdominal fat, intrahepatic lipid, and insulin sensitivity in obese adolescent boys: a randomized, controlled trial. Diabetes. 2012 Nov;61(11):2787-95. doi: 10.2337/db12-0214. Epub 2012 Jun 29.
- Background: PubMed 27379904Zhang HJ, He J, Pan LL, Ma ZM, Han CK, Chen CS, Chen Z, Han HW, Chen S, Sun Q, Zhang JF, Li ZB, Yang SY, Li XJ, Li XY. Effects of Moderate and Vigorous Exercise on Nonalcoholic Fatty Liver Disease: A Randomized Clinical Trial. JAMA Intern Med. 2016 Aug 1;176(8):1074-82. doi: 10.1001/jamainternmed.2016.3202.
- Background: PubMed 27521509Houghton D, Thoma C, Hallsworth K, Cassidy S, Hardy T, Burt AD, Tiniakos D, Hollingsworth KG, Taylor R, Day CP, McPherson S, Anstee QM, Trenell MI. Exercise Reduces Liver Lipids and Visceral Adiposity in Patients With Nonalcoholic Steatohepatitis in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2017 Jan;15(1):96-102.e3. doi: 10.1016/j.cgh.2016.07.031. Epub 2016 Aug 10.
- Background: PubMed 21206486Kistler KD, Brunt EM, Clark JM, Diehl AM, Sallis JF, Schwimmer JB; NASH CRN Research Group. Physical activity recommendations, exercise intensity, and histological severity of nonalcoholic fatty liver disease. Am J Gastroenterol. 2011 Mar;106(3):460-8; quiz 469. doi: 10.1038/ajg.2010.488. Epub 2011 Jan 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qun Zhang, Professor principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic Exercise in people with Non-alcoholic Fatty Liver Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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 11 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 20 Sep 2024. 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 China. 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?
Changes from baseline in the liver fat content at 3 months after intervention. (time frame: 3 months). 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 NCT04882644, which also lists 4 linked publications.
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 20 Sep 2024.