Impact of Live Streaming Exercise on Liver Health in MASLD Pregnant Women

Official title

Evaluation of the Effect of Live Streaming Exercise on the Improvement of Hepatic Steatosis and Fibrosis in Pregnant Women with MASLD and Its Study Based on the Liver-gut Axis Mechanism.

Overview

Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) is a clinical and pathological syndrome characterized primarily by excessive intracellular fat accumulation in the liver, excluding alcohol-related and other specific causes. Recent research has identified an association between MASLD and an increased risk of pregnancy-related complications and adverse pregnancy outcomes, including gestational diabetes, preeclampsia, preterm birth, and large-for-gestational-age infants. MASLD in pregnant women poses multiple risks to maternal and infant health. Regular physical exercise during pregnancy has been shown to effectively reduce the incidence of pregnancy complications and adverse outcomes, while also alleviating hepatic steatosis and fibrosis. This study is a randomized controlled trial aimed at exploring the feasibility and effectiveness of online exercise interventions for pregnant women with MASLD, as well as conducting a cost-effectiveness analysis and investigating the underlying physiological mechanisms based on the liver-gut axis. The findings are intended to provide scientific evidence and practical recommendations for managing pregnancy health and intervening in MASLD during pregnancy.

Interventions

• Behavioral Live Streaming Exercise
  Participants try to achieve 150 minutes of moderate-vigorous training per week. The exercise program includes live streaming exercise by trained health professionals, including pregnancy-specific exercises, with professional pregnancy trainers to provide guidance and support when needed.

Primary outcome measures

• Liver steatosis [Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy]
• Liver stiffness measurement [Time frame: Changes from the 14th week to 36 weeks +6 days of pregnancy]

Secondary outcome measures (12)

• Gestational weight change [Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy]
• Incidence of pregnancy-related complications including gestational diabetes mellitus, gestational hypertension and related diseases [Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy]
• Changes in fasting serum lipids(TG, TC, LDL, HDL) [Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy]
• Changes in fasting blood glucose [Time frame: Changes from the 14th week to 36 weeks +6 days of pregnancy]
• Changes in blood pressure [Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy]
• Changes in alanine aminotransferase (ALT) [Time frame: Changes from the 14th week to 36 weeks +6 days of pregnancy]
• Changes in aspartate aminotransferase (AST) [Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy]
• Maternal physical activity [Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy]
• Maternal sleep quality [Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy]
• Maternal mental health [Time frame: Changes from the 14th week to 36 weeks + 6 days of pregnancy]
• Fetal height and weight [Time frame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.]
• Height and weight at birth [Time frame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.]

Eligibility criteria

Inclusion criteria

• Singleton pregnancy;
• Gestational age ≤10-13+6 weeks at enrollment;
• Age between 20 and 45 years;
• Patients diagnosed with MASLD;
• Signed informed consent.

Exclusion criteria

• Cervical length ≤ 25 mm;
• History of threatened abortion;
• Exercise contraindications or doctor advice not to exercise during pregnancy;
• Current or previous use of drugs that affect body weight (such as hormones);
• Patients with chronic hepatitis virus or other chronic liver diseases, excluding MASLD;
• Non-natural conception or infertility treatment;
• Any previous medication for hypertension, diabetes, heart disease, kidney disease, systemic lupus erythematosus, thyroid disease or mental illness;
• Participating in other pregnancy intervention research projects.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Younossi ZM, Golabi P, Paik JM, Henry A, Van Dongen C, Henry L. The global epidemiology of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH): a systematic review. Hepatology. 2023 Apr 1;77(4):1335-1347. doi: 10.1097/HEP.0000000000000004. Epub 2023 Jan 3. PMID 36626630
• Zhou F, Zhou J, Wang W, Zhang XJ, Ji YX, Zhang P, She ZG, Zhu L, Cai J, Li H. Unexpected Rapid Increase in the Burden of NAFLD in China From 2008 to 2018: A Systematic Review and Meta-Analysis. Hepatology. 2019 Oct;70(4):1119-1133. doi: 10.1002/hep.30702. PMID 31070259
• Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016 Jul;64(1):73-84. doi: 10.1002/hep.28431. Epub 2016 Feb 22. PMID 26707365
• Qian Y, Zhang Y, Fan X, Yan H, Li X, Fan Y, Song Y, Ma S, Hu Z, Gao X, Yang J. Nonalcoholic Fatty Liver Disease and Adverse Pregnancy Outcomes in Women With Normal Prepregnant Weight. J Clin Endocrinol Metab. 2023 Jan 17;108(2):463-471. doi: 10.1210/clinem/dgac567. PMID 36181486
• Lee SM, Cho GJ, Wi WY, Norwitz ER, Koo BK, Lee J, Jung YM, Kwak SH, Park CW, Jun JK, Joo SK, Oh MJ, Kim W, Park JS. Metabolic dysfunction-associated fatty liver disease as a risk factor for adverse outcomes in subsequent pregnancy: a nationwide cohort study. Hepatol Int. 2023 Apr;17(2):367-376. doi: 10.1007/s12072-022-10458-w. Epub 2022 Dec 21. PMID 36542262
• Chai TY, Byth K, George J, Pasupathy D, Cheung NW. Elevated Hepatic Steatosis Index is Associated with the Development of Adverse Maternal, but Not Adverse Neonatal, Outcomes: A Retrospective Cohort Study. Int J Womens Health. 2023 Apr 13;15:589-598. doi: 10.2147/IJWH.S399085. eCollection 2023. PMID 37077282
• El Jamaly H, Eslick GD, Weltman M. Systematic review with meta-analysis: Non-alcoholic fatty liver disease and the association with pregnancy outcomes. Clin Mol Hepatol. 2022 Jan;28(1):52-66. doi: 10.3350/cmh.2021.0205. Epub 2021 Sep 17. PMID 34530527
• Sarkar M, Grab J, Dodge JL, Gunderson EP, Rubin J, Irani RA, Cedars M, Terrault N. Non-alcoholic fatty liver disease in pregnancy is associated with adverse maternal and perinatal outcomes. J Hepatol. 2020 Sep;73(3):516-522. doi: 10.1016/j.jhep.2020.03.049. Epub 2020 Jun 9. PMID 32531415

Identifiers

NCT: NCT06682663 · IRB00001052-24122

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗