Screening for GDM in Women With PCOS and Controls

NCT ID: NCT02183558

Last Updated: 2022-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Polycystic Ovary Syndrome Gestational Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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OGTT by randomization

Women without risk factors for GDM are offered OGTT in gestational week 28

Group Type EXPERIMENTAL

OGTT by randomization

Intervention Type OTHER

OGTT by indication

Women with risk factors for OGTT are offered diagnostic 2 hour OGTT in pregnancy week 28

Group Type EXPERIMENTAL

OGTT by indication

Intervention Type OTHER

Interventions

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OGTT by randomization

Intervention Type OTHER

OGTT by indication

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Moving from Odense during pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Region of Southern Denmark

OTHER

Sponsor Role collaborator

Municipality of Odense

OTHER_GOV

Sponsor Role collaborator

University of Southern Denmark

OTHER

Sponsor Role collaborator

Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Marianne Andersen

DMSci

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marianne Andersen, DMSci

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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OdenseUH

Odense, , Denmark

Site Status

Countries

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Denmark

References

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Al-Jorani H, Jensen RC, Jensen TK, Christesen HT, Jorgensen JS, Bacmeister L, Dechend R, Glintborg D, Jensen BL, Andersen MS. Diurnal Urinary Aldosterone Excretion and Potassium Intake During Pregnancy Are Associated With High Normal Blood Pressure in Early Childhood. J Am Heart Assoc. 2025 Jul 15;14(14):eJAHA2025042165T. doi: 10.1161/JAHA.124.042165. Epub 2025 Jul 3.

Reference Type DERIVED
PMID: 40611483 (View on PubMed)

Other Identifiers

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Glucose OBK

Identifier Type: OTHER

Identifier Source: secondary_id

GDM OBK

Identifier Type: -

Identifier Source: org_study_id

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