Clinical trial NCT06682663: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Dysfunction-associated Steatotic Liver Disease
Keywords: Randomized Controlled Trial
Live streaming exercise
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Beijing Friendship Hospital
name: W.F. Maternal and Child Health Hospital
First posted: 2024-11-12
Enrollment: 220
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will randomize eligible MASLD pregnant women into two groups: a control group and an intervention group. The control group will receive standard prenatal care, while the intervention group will receive supervised exercise guidance starting from the 14th week of pregnancy and continuing through the 36+6th week. Quality control, data collection, and biological sample collection will be conducted throughout the intervention period.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Liver steatosis
timeFrame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
measure: Liver stiffness measurement
timeFrame: Changes from the 14th week to 36 weeks +6 days of pregnancy
Secondary outcomes:
measure: Gestational weight change
timeFrame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
measure: Incidence of pregnancy-related complications including gestational diabetes mellitus, gestational hypertension and related diseases
timeFrame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
measure: Changes in fasting serum lipids(TG, TC, LDL, HDL)
timeFrame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
measure: Changes in fasting blood glucose
timeFrame: Changes from the 14th week to 36 weeks +6 days of pregnancy
measure: Changes in blood pressure
timeFrame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
measure: Changes in alanine aminotransferase (ALT)
timeFrame: Changes from the 14th week to 36 weeks +6 days of pregnancy
measure: Changes in aspartate aminotransferase (AST)
timeFrame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
measure: Maternal physical activity
timeFrame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
measure: Maternal sleep quality
timeFrame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
measure: Maternal mental health
timeFrame: Changes from the 14th week to 36 weeks + 6 days of pregnancy
measure: Fetal height and weight
timeFrame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
measure: Height and weight at birth
timeFrame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
measure: Baby's Apgar Score
timeFrame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
measure: Preterm birth
timeFrame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
measure: Small gestational week
timeFrame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
measure: Large gestational week
timeFrame: fetal data were collected from gestational week 14 to 36 week +6 days, other data collected on the delivery.
Other outcomes:
Locations:
Study officials:
affiliation: Peking University
name: Hui Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
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