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

Not Applicable

Not yet recruiting

• Conditions: GDM

• Registration Number: NCT07141173
• Lead Sponsor: Tianjin Central Hospital of Gynecology Obstetrics

Brief 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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-18
• Study Start: 2025-08-20
• Study First Submitted QC: 2025-08-25
• Last Update Submitted: 2025-08-25
• Study First Posted: 2025-08-26
• Last Update Posted: 2025-08-26
• Primary Completion: 2027-08-20
• Study Completion: 2027-08-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 604

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (1)

Tianjin Central Hospital of Gynecology Obstetrics; 🇨🇳 Tianjin, China