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OpenTrials
Completed

NCT Number: NCT04539288

Serum Biomarkers Associated With Postpartum T2DM in Women With GDM

Gestational diabetes mellitus (GDM) is commonly linked to the development of type 2 diabetes mellitus (T2DM). There is a need to characterize metabolic changes associated with GDM in order to find novel biomarkers for T2DM.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Obstetrics and Gynechology Department of the 1st affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

About this study

GDM, a common complication of pregnancy, affects 17.8% of pregnancies worldwide per year. Women with a history of GDM have an approximately 7-fold higher risk for developing T2DM in the future than women without GDM. However, data on the factors associated with the development of T2DM in women with GDM are not widely available.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women who were dignosed GDM.
  • Women with singleton pregnancy.
  • Give birth in the First Affiliated Hospital in Sun Yat-sen University.

Exclusion criteria

  • Women who were diagnosed PGDM.
  • Younger than 18 years old.
  • Older than 45 years old.
  • Multiple pregnancy.
  • Diagnosed DM before.
  • Complicationg other diseases, like hypertension, thyroid diseases, etc.
  • Taking any drug affect glucose and lipid metabolism.

Treatment and study plan

Primary outcomes

  1. T2DM

    Time frame: 4-6 weeks.

    Women with GDM develop T2DM in postpartum.

Secondary outcomes

  1. IGT

    Time frame: 4-6 weeks.

    Women with GDM were impaired glucose intolerance in postpartum.

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

Pregnancy to Postpartum Transition of Serum Biomarkers in Women With Gestational Diabetes

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Sep 4, 2020
Registry last updated
Sep 7, 2020

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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