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OpenTrials
Completed

NCT Number: NCT02183558

Screening for GDM in Women With PCOS and Controls

Women with polycystic ovary syndrome (PCOS) are often insulin resistant. During pregnancy, insulin sensitivity decreases. The investigators examine glucose metabolism during oral glucose tolerance test and the incidense of gestational diabetes mellitus in a prospective cohort of pregnant women with PCOS and controls.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gestational Diabetes Mellitus Glucose Metabolism Disorders Gonadal Disorders Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OdenseUH

Odense, 5230, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnancy achieved during 2010-2012
  • Residents of the municipality of Odense

Exclusion criteria

  • Moving from Odense during pregnancy

Treatment and study plan

OGTT by randomization

Other

OGTT by indication

Other

Primary outcomes

  1. Gestational diabetes mellitus

    Time frame: 2 years

    Gestational diabetes mellitus diagnosed by oral glucose tolerance test in gestational week 28 in women with and without risk factors for gestational diabetes mellitus.

  2. Gestational Diabetes Mellitus

    Time frame: Gestational week 28

    Gestational diabetes mellitus is diagnosed by 2 hour 75 gram oral glucose tolerance test in gestational week 28

Secondary outcomes

  1. Anthropometric measures in offspring

    Time frame: At birth

    The association between blood glucose values and anthropometric measures (birth length, weight and abdominal circumference) at birth in the offspring is investigated

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Collaborators

  • Municipality of Odense
  • Region of Southern Denmark
  • University of Southern Denmark

Registry information

Official study title

Glucose Metabolism and Screening for Gestational Diabetes Mellitus According to Different Sets of Criteria in Women With Polycystic Ovary Syndrome and Controls

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Jul 8, 2014
Registry last updated
Jan 13, 2022

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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