Screening for GDM in Women With PCOS and Controls

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02183558
• Other study ID #: GDM OBK
• Secondary ID: Glucose OBK
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: June 2014

Study information

• Verified date: December 2021
• Source: Odense University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: June 2014
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnancy achieved during 2010-2012

• Residents of the municipality of Odense

Exclusion Criteria:

• Moving from Odense during pregnancy

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• OGTT by randomization

• OGTT by indication

Locations

Country	Name	City	State
Denmark	OdenseUH	Odense

Sponsors (4)

Lead Sponsor	Collaborator
Odense University Hospital	Municipality of Odense, Region of Southern Denmark, University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	At birth