Effect of Early Lifestyle Intervention on Perinatal Outcomes in High-risk Women for Gestational Hyperglycemia

NCT07141173 · tracked via the Priya Life Science China tracker

Sponsor

Tianjin Central Hospital of Gynecology Obstetrics

Phase

Not applicable

Started

2025-08-20

Last updated

2025-08-26

Condition(s) studied

GDM

Investigational drug(s) / intervention(s)

Individual lifestyle management

Individual lifestyle management: Manage the diet, exercise, weight and healthy lifestyle of pregnant women

Study summary

This study aims to explore whether early intervention for high-risk groups of gestational hyperglycemia can improve insulin resistance and effectively prevent the occurrence of GDM, and evaluate which pathophysiological subtypes of GDM have the best effect on improving maternal and fetal adverse prognosis, so as to provide evidence for stratified management and individualized clinical intervention of high glucose groups in pregnancy

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

45 Years

Healthy volunteers

Accepted

Inclusion Criteria: * 18-55 years old * 6-14 weeks of pregnancy * at least one risk factor for GDM * signed a written informed consent Exclusion Criteria: * Individuals diagnosed with diabetes or prediabetes prior to pregnancy * currently taking medications affecting blood glucose levels such as metformin * women at risk of miscarriage * individuals with chronic conditions (such as uncontrolled hypertension, severe heart disease) * those with movement disorders or contraindicated conditions for physical activity * patients undergoing gastrointestinal surgeries that alter glucose absorption * those unable to maintain regular prenatal care (such as non-compliance with medical instructions or mental health issues).

Primary outcome measure(s)

The incidence of gestational diabetes(GDM) — 24-28 weeks pregnant
The 75g 2h oral glucose tolerance test is performed at 24-28 weeks of gestation, and the cut-off points of venous blood glucose values are 5.1mmol/L (fasting), 10.0mmol/L (1h after glucose load), 8.5mmol/L (2h after glucose load). If any one of the three blood glucose measures is above the cut-off points, then GDM is diagnosed..

Trial sites (1)

Facility	City	Region	Status
Tianjin Central Hospital of Gynecology Obstetrics	Tianjin	China

More Tianjin Central Hospital of Gynecology Obstetrics trials in China

Early Prediction of Gestational Diabetes in High-risk Women Based on Breath Metabolomics Enrolling by invitation

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Couple-Coordinated Lifestyle Intervention for Women With a History of Gestational Diabetes Mellitus Starting soon

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07141173 on ClinicalTrials.gov ↗ ← All trials in China