Clinical trial NCT04882644: 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
Overall status: COMPLETED
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: Lean NAFLD
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Nanjing Medical University
First posted: 2021-05-12
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 1. Subjects with NAFLD determined by MRI-PDFF (liver fat\&amp;gt;5%).

  2. Subjects with BMI\&amp;lt;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 \[i.e. myocardial infarction, arrhythmia, heart failure (New York Heart Association III or IV), uncontrolled hypertension (i.e. systolic blood pressure \&amp;gt;180 mmHg, and/or diastolic blood pressure \&amp;gt;100 mmHg)\].

  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, \&amp;gt;30 min/time).

  11. Subjects with poor adherence.

Primary outcomes:
measure: Changes from baseline in the liver fat content at 3 months after intervention.
timeFrame: 3 months
Secondary outcomes:
measure: Changes from baseline in body mass index (BMI) at 3/12 months after intervention.
timeFrame: 3 months, 12 months
measure: Changes from baseline in waist hip ratio(WHR) at 3/12 months after intervention.
timeFrame: 3 months, 12 months
measure: Changes from baseline in abdominal fat at 3/12 months after intervention.
timeFrame: 3 months, 12 months
measure: Changes from baseline in blood pressure at 3/12 months after intervention.
timeFrame: 3 months, 12 months
measure: Changes from baseline in triglycerides at 3/12 months after intervention.
timeFrame: 3 months, 12 months
measure: Changes from baseline in total cholesterol at 3/12 months after intervention.
timeFrame: 3 months, 12 months
measure: Changes from baseline in fasting blood glucose at 3/12 months after intervention.
timeFrame: 3 months, 12 months
measure: Changes from baseline in fasting insulin at 3/12 months after intervention.
timeFrame: 3 months, 12 months
measure: Changes from baseline in glucose level for oral glucose tolerance test (OGTT) at 3/12 months after intervention.
timeFrame: 3 months, 12 months
measure: Changes from baseline in homeostasis model assessment of insulin resistance (HOMA-IR) at 3/12 months after intervention.
timeFrame: 3 months, 12 months
measure: Changes from baseline in homeostasis model assessment of β-cell function (HOMA-β) at 3/12 months after intervention.
timeFrame: 3 months, 12 months
measure: Changes from baseline in the liver fat content at 12 months after intervention.
timeFrame: 12 months
Other outcomes:
Locations:
city: NanJing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Qun Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.