Polycystic Ovary SyndromeNCT02183558
Screening for GDM in Women With PCOS and Controls
A study testing OGTT by randomization and OGTT by indication in people with Polycystic Ovary Syndrome and Gestational Diabetes Mellitus, run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome, Gestational Diabetes Mellitus
- What is being tested?
- OGTT by randomization and OGTT by indication
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2010to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnancy achieved during 2010-2012
- Residents of the municipality of Odense
Who cannot join
- Moving from Odense during pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glucose Metabolism and Screening for Gestational Diabetes Mellitus According to Different Sets of Criteria in Women With Polycystic Ovary Syndrome 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.
- Being tested
- OGTT by randomization, OGTT by indication
- Keywords
- PCOS, GDM, OGTT, Glucose metabolism
- Medical subject headings
- Polycystic Ovary Syndrome, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OGTT by randomizationOther
OGTT by indicationOther
| Study group | Role | What they receive |
|---|---|---|
| OGTT by randomization | Experimental | Women without risk factors for GDM are offered OGTT in gestational week 28 Receives: Other: OGTT by randomization |
| OGTT by indication | Experimental | Women with risk factors for OGTT are offered diagnostic 2 hour OGTT in pregnancy week 28 Receives: Other: OGTT by indication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Gestational Diabetes Mellitus
Gestational diabetes mellitus is diagnosed by 2 hour 75 gram oral glucose tolerance test in gestational week 28
Measured: Gestational week 28
Secondary outcomes (1)
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
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startJan 2010
- Primary completionSep 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, Municipality of Odense, University of Southern Denmark
- Responsible party
- Principal investigator, Marianne Andersen, Odense University Hospital
- Investigators
- Marianne Andersen, DMSci, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02183558
- Sponsor's protocol ID
- GDM OBK
- Other IDs
- Glucose OBK
- Status last verified
- Dec 2021
- First submitted
- 20 Jun 2014
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 40611483
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Metabolism and Screening for Gestational Diabetes Mellitus According to Different Sets of Criteria in Women With Polycystic Ovary Syndrome and Controls
- ClinicalTrials.gov ID
- NCT02183558
- Acronym / sponsor ID
- GDM OBK
- Keywords
- PCOS, GDM, OGTT, Glucose metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,500 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, Municipality of Odense, University of Southern Denmark
- Study start
- Jan 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OGTT by randomization | Experimental | Other: OGTT by randomizationWomen without risk factors for GDM are offered OGTT in gestational week 28 |
| OGTT by indication | Experimental | Other: OGTT by indicationWomen with risk factors for OGTT are offered diagnostic 2 hour OGTT in pregnancy week 28 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnancy achieved during 2010-2012
- Residents of the municipality of Odense
Key exclusion criteria (1 listed)
- Moving from Odense during pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OGTT by randomization | Other | OGTT by randomization |
| OGTT by indication | Other | OGTT by indication |
Primary outcome
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.
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
1 secondary outcome
Anthropometric measures in offspring
Time frame: At birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Derived from this study: PubMed 40611483Al-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marianne Andersen, DMSci principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OGTT by randomization and OGTT by indication in people with Polycystic Ovary Syndrome and Gestational Diabetes Mellitus, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gestational diabetes mellitus (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02183558, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.