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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 主要终点
- Liver steatosis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Singleton pregnancy;
- •Gestational age ≤10-13+6 weeks at enrollment;
- •Age between 20 and 45 years;
- •Patients diagnosed with MASLD;
- •Signed informed consent.
排除标准
- •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.
结局指标
主要结局
Liver steatosis
时间窗: Changes from the 14th week to 36 weeks + 6 days of pregnancy
LiSA, by Hepatus, Mindray, China；
Liver stiffness measurement
时间窗: Changes from the 14th week to 36 weeks +6 days of pregnancy
E, by Hepatus, Mindray, China
次要结局
- Gestational weight change(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(Changes from the 14th week to 36 weeks + 6 days of pregnancy)
- Changes in fasting serum lipids(TG, TC, LDL, HDL)(Changes from the 14th week to 36 weeks + 6 days of pregnancy)
- Changes in fasting blood glucose(Changes from the 14th week to 36 weeks +6 days of pregnancy)
- Changes in blood pressure(Changes from the 14th week to 36 weeks + 6 days of pregnancy)
- Changes in alanine aminotransferase (ALT)(Changes from the 14th week to 36 weeks +6 days of pregnancy)
- Changes in aspartate aminotransferase (AST)(Changes from the 14th week to 36 weeks + 6 days of pregnancy)
- Maternal physical activity(Changes from the 14th week to 36 weeks + 6 days of pregnancy)
- Maternal sleep quality(Changes from the 14th week to 36 weeks + 6 days of pregnancy)
- Maternal mental health(Changes from the 14th week to 36 weeks + 6 days of pregnancy)
- Fetal height and weight(fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.)
- Height and weight at birth(fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.)
- Baby's Apgar Score(fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.)
- Preterm birth(fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.)
- Small gestational week(fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.)
- Large gestational week(fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.)