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NCT Number: NCT07141173

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

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

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Key information

Conditions

GDM

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Individual lifestyle management

Behavioral

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

Primary outcomes

  1. The incidence of gestational diabetes(GDM)

    Time frame: 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..

Study contacts

Contact information is provided by the study sponsor or research team.

Yifan Fan

CONTACT

[email protected]

+86 18322337116

Sponsors and collaborators

Lead sponsor

Tianjin Central Hospital of Gynecology Obstetrics

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2025
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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