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Screening for GDM in Women With PCOS and Controls

Primary Purpose

Polycystic Ovary Syndrome, Gestational Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
OGTT by randomization
OGTT by indication
Sponsored by
Odense University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Polycystic Ovary Syndrome focused on measuring PCOS, GDM, OGTT, Glucose metabolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Moving from Odense during pregnancy

Sites / Locations

  • OdenseUH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

OGTT by randomization

OGTT by indication

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
June 20, 2014
Last Updated
December 23, 2021
Sponsor
Odense University Hospital
Collaborators
Region of Southern Denmark, Municipality of Odense, University of Southern Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02183558
Brief Title
Screening for GDM in Women With PCOS and Controls
Official Title
Glucose Metabolism and Screening for Gestational Diabetes Mellitus According to Different Sets of Criteria in Women With Polycystic Ovary Syndrome and Controls
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
Collaborators
Region of Southern Denmark, Municipality of Odense, University of Southern Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Gestational Diabetes Mellitus
Keywords
PCOS, GDM, OGTT, Glucose metabolism

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OGTT by randomization
Arm Type
Experimental
Arm Description
Women without risk factors for GDM are offered OGTT in gestational week 28
Arm Title
OGTT by indication
Arm Type
Experimental
Arm Description
Women with risk factors for OGTT are offered diagnostic 2 hour OGTT in pregnancy week 28
Intervention Type
Other
Intervention Name(s)
OGTT by randomization
Intervention Type
Other
Intervention Name(s)
OGTT by indication
Primary Outcome Measure Information:
Title
Gestational diabetes mellitus
Description
Gestational diabetes mellitus diagnosed by oral glucose tolerance test in gestational week 28 in women with and without risk factors for gestational diabetes mellitus.
Time Frame
2 years
Title
Gestational Diabetes Mellitus
Description
Gestational diabetes mellitus is diagnosed by 2 hour 75 gram oral glucose tolerance test in gestational week 28
Time Frame
Gestational week 28
Secondary Outcome Measure Information:
Title
Anthropometric measures in offspring
Description
The association between blood glucose values and anthropometric measures (birth length, weight and abdominal circumference) at birth in the offspring is investigated
Time Frame
At birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnancy achieved during 2010-2012 Residents of the municipality of Odense Exclusion Criteria: Moving from Odense during pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Andersen, DMSci
Organizational Affiliation
Odense University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
OdenseUH
City
Odense
ZIP/Postal Code
5230
Country
Denmark

12. IPD Sharing Statement

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Screening for GDM in Women With PCOS and Controls

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