Gestational DiabetesPS-GDM-2022NCT05392231
Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers in GDM
An observational study of Gestational Diabetes, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP) for gestational diabetes mellitus (GDM). Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- How many people
- 109 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Feb 2022to 10 May 2022
- Phase
- Observational
- 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 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: With a design of prospective observational study, this research was carried out in the Perinatology Clinic of Haseki Hospital, affiliated with the University of Health Sciences, in Istanbul, between September 2021 and April 2022, following the approval of the local ethics committee (date: February 09, 2022, Registry No: 05-2022) and the valid Helsinki Declaration. After all the objectives of this work and context of all the procedures that could be undertaken were properly explained to each pregnant woman, the participant was requested to sign an informed written consent form.
Who may be able to join
- Maternal age between 18 and 42 years
- Gestational age between 20 and 28 weeks
Who cannot join
- Multiple pregnancies
- Pregestational diabetes
- Fetal congenital malformations
- Placental and amniotic fluid abnormalities
- Preeclampsia
- Severe systemic disease
- Long-term systemic drug usage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul
About this study
Official title: Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers Glycated Albumin and Insulin-regulated Aminopeptidase in Women With Gestational Diabetes Mellitus
The investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP) for gestational diabetes mellitus (GDM).
Read the detailed description
The investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP) for gestational diabetes mellitus (GDM).In this prospective observational study including 109 pregnant women, the fetal pancreas size and maternal serum biomarkers GA and IRAP were measured at the gestational age of 20-22 weeks and later at the gestational age of 24-28 weeks, in 19 participants of them, GDM was confirmed with the 75-g oral glucose tolerance test (OGTT) and the fetal pancreas size was measured in all the participants again.
- Conditions
- Gestational Diabetes
- Medical subject headings
- Diabetes, Gestational
What is being measured
The primary outcome is the main question the study is designed to answer.
Early prediction of gestational diabetes
Early prediction of gestational diabetes by the fetal pancreas measurement with ultrasound and maternal serum biomarkers glycated albumin and insulin-regulated aminopeptidase measured with ELISA
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start10 Feb 2022
- Primary completion30 Apr 2022
- Study completion10 May 2022
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 Gestational DiabetesStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05392231
- Sponsor's protocol ID
- 05-2022
- Acronym
- PS-GDM-2022
- Status last verified
- May 2022
- First submitted
- 22 May 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guleroglu FY, Ozmen AB, Bakirci IT, Dogu SY, Yilmaz I, Cetin A. Fetal pancreas size and maternal serum biomarkers glycated albumin and insulin-regulated aminopeptidase provide no potential for early prediction of gestational diabetes mellitus. Arch Gynecol Obstet. 2023 Nov;308(5):1505-1514. doi: 10.1007/s00404-022-06860-2. Epub 2022 Nov 27.
PubMed 36436013
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Fetal Pancreatic Size and Maternal Serum Biomarkers Glycated Albumin and Insulin-regulated Aminopeptidase in Women With Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05392231
- Acronym / sponsor ID
- PS-GDM-2022 / 05-2022
- Conditions
- Gestational Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 26 May 2022 (actual)
- 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.
The investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP) for gestational diabetes mellitus (GDM).
Detailed description
The investigators aimed to determine the predictive values of fetal pancreas size and maternal serum biomarkers glycated albumin (GA) and insulin-regulated aminopeptidase (IRAP) for gestational diabetes mellitus (GDM).In this prospective observational study including 109 pregnant women, the fetal pancreas size and maternal serum biomarkers GA and IRAP were measured at the gestational age of 20-22 weeks and later at the gestational age of 24-28 weeks, in 19 participants of them, GDM was confirmed with the 75-g oral glucose tolerance test (OGTT) and the fetal pancreas size was measured in all the participants again.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- With a design of prospective observational study, this research was carried out in the Perinatology Clinic of Haseki Hospital, affiliated with the University of Health Sciences, in Istanbul, between September 2021 and April 2022, following the approval of the local ethics committee (date: February 09, 2022, Registry No: 05-2022) and the valid Helsinki Declaration. After all the objectives of this work and context of all the procedures that could be undertaken were properly explained to each pregnant woman, the participant was requested to sign an informed written consent form.
Key inclusion criteria (2 listed)
- Maternal age between 18 and 42 years
- Gestational age between 20 and 28 weeks
Key exclusion criteria (7 listed)
- Multiple pregnancies
- Pregestational diabetes
- Fetal congenital malformations
- Placental and amniotic fluid abnormalities
- Preeclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early prediction of gestational diabetes
Time frame: Two months
Early prediction of gestational diabetes by the fetal pancreas measurement with ultrasound and maternal serum biomarkers glycated albumin and insulin-regulated aminopeptidase measured with ELISA
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 1 Jun 2022.
- Derived from this study: PubMed 36436013Guleroglu FY, Ozmen AB, Bakirci IT, Dogu SY, Yilmaz I, Cetin A. Fetal pancreas size and maternal serum biomarkers glycated albumin and insulin-regulated aminopeptidase provide no potential for early prediction of gestational diabetes mellitus. Arch Gynecol Obstet. 2023 Nov;308(5):1505-1514. doi: 10.1007/s00404-022-06860-2. Epub 2022 Nov 27.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
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 7 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 1 Jun 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 Turkey (Türkiye). 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?
Early prediction of gestational diabetes (time frame: Two months). 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 NCT05392231, 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 1 Jun 2022.