NCT02183558

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2014

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 8, 2014

Completed
Last Updated

January 13, 2022

Status Verified

December 1, 2021

Enrollment Period

2.7 years

First QC Date

June 20, 2014

Last Update Submit

December 23, 2021

Conditions

Polycystic Ovary SyndromeGestational Diabetes Mellitus

Keywords

PCOSGDMOGTTGlucose metabolism

Outcome Measures

Primary Outcomes (2)

  • Gestational diabetes mellitus

    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 years

  • Gestational Diabetes Mellitus

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

    Gestational week 28

Secondary Outcomes (1)

  • Anthropometric measures in offspring

    At birth

Study Arms (2)

OGTT by randomization

EXPERIMENTAL

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

Other: OGTT by randomization

OGTT by indication

EXPERIMENTAL

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

Other: OGTT by indication

Interventions

OGTT by randomizationOTHER
OGTT by randomization
OGTT by indicationOTHER
OGTT by indication

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Moving from Odense during pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OdenseUH

Odense, 5230, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 40611483DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeDiabetes, Gestational

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesPregnancy ComplicationsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Marianne Andersen, DMSci

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DMSci

Study Record Dates

First Submitted

June 20, 2014

First Posted

July 8, 2014

Study Start

January 1, 2010

Primary Completion

September 1, 2012

Study Completion

June 1, 2014

Last Updated

January 13, 2022

Record last verified: 2021-12

Locations

DK(1)