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Effects of Aerobic Exercise on Lean Non-alcoholic Fatty Liver Disease (NAFLD)

Primary Purpose

Non-alcoholic Fatty Liver Disease

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Aerobic Exercise
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease focused on measuring Lean NAFLD

Eligibility Criteria

30 Years - 55 Years (Adult)Does not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

    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.

Sites / Locations

  • The First Affiliated Hospital with Nanjing Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Aerobic Exercise Intervention Group

Control Group

Arm Description

The subjects receive an intensive aerobic exercise for 3 months and a health education content for 12 months.

The subjects do not change their physical activity routine and receive a health education content for 12 months.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).
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).
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).
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)
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)
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)
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)
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)
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)
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)
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)
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)

Full Information

First Posted
April 28, 2021
Last Updated
February 16, 2022
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04882644
Brief Title
Effects of Aerobic Exercise on Lean Non-alcoholic Fatty Liver Disease (NAFLD)
Official Title
Effects of Aerobic Exercise on Lean Non-alcoholic Fatty Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 14, 2021 (Actual)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
Keywords
Lean NAFLD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Aerobic Exercise Intervention Group
Arm Type
Experimental
Arm Description
The subjects receive an intensive aerobic exercise for 3 months and a health education content for 12 months.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The subjects do not change their physical activity routine and receive a health education content for 12 months.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from baseline in the liver fat content at 3 months after intervention.
Description
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)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Changes from baseline in body mass index (BMI) at 3/12 months after intervention.
Description
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).
Time Frame
3 months, 12 months
Title
Changes from baseline in waist hip ratio(WHR) at 3/12 months after intervention.
Description
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).
Time Frame
3 months, 12 months
Title
Changes from baseline in abdominal fat at 3/12 months after intervention.
Description
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).
Time Frame
3 months, 12 months
Title
Changes from baseline in blood pressure at 3/12 months after intervention.
Description
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)
Time Frame
3 months, 12 months
Title
Changes from baseline in triglycerides at 3/12 months after intervention.
Description
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)
Time Frame
3 months, 12 months
Title
Changes from baseline in total cholesterol at 3/12 months after intervention.
Description
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)
Time Frame
3 months, 12 months
Title
Changes from baseline in fasting blood glucose at 3/12 months after intervention.
Description
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)
Time Frame
3 months, 12 months
Title
Changes from baseline in fasting insulin at 3/12 months after intervention.
Description
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)
Time Frame
3 months, 12 months
Title
Changes from baseline in glucose level for oral glucose tolerance test (OGTT) at 3/12 months after intervention.
Description
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)
Time Frame
3 months, 12 months
Title
Changes from baseline in homeostasis model assessment of insulin resistance (HOMA-IR) at 3/12 months after intervention.
Description
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)
Time Frame
3 months, 12 months
Title
Changes from baseline in homeostasis model assessment of β-cell function (HOMA-β) at 3/12 months after intervention.
Description
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)
Time Frame
3 months, 12 months
Title
Changes from baseline in the liver fat content at 12 months after intervention.
Description
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)
Time Frame
12 months

10. Eligibility

Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qun Zhang, Professor
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital with Nanjing Medical University
City
NanJing
ZIP/Postal Code
210029
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22751691
Citation
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.
Results Reference
background
PubMed Identifier
27379904
Citation
Zhang 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.
Results Reference
background
PubMed Identifier
27521509
Citation
Houghton 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.
Results Reference
background
PubMed Identifier
21206486
Citation
Kistler 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.
Results Reference
background

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Effects of Aerobic Exercise on Lean Non-alcoholic Fatty Liver Disease (NAFLD)

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