Gestational Diabetes Mellitus in PregnancyNCT04054843
Afamin in Gestational Diabetes Mellitus
An observational study of Gestational Diabetes Mellitus in Pregnancy, run by Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study includes pregnancies in 11 to 14 th gestational weeks. Investigators will sample maternal plasma in the first trimester and analyze maternal plasma afamin values. All these women will then be screened by two step OGTT. Investigators will compare afamin levels in GDM and control groups. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- Afamin
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 15 Mar 2020
- 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 35 years
- Women only
- Adult
Study population: Women within 11 and 14 weeks of gestational weeks
Who may be able to join
- singleton pregnancy,
- having no fetal anomalies
- having no pregestational diabetes
- having no underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders)
- age >18 or < 35 years
- fasting glucose level < 105 mg/dL
Who cannot join
- multiple pregnancy
- fetal anomalies
- pregestational diabetes
- underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders)
- age <18 or > 35 years
- fasting glucose level > 105 mg/dL or random glucose level > 200 mg/dL
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Ankara
About this study
Official title: Afamin Levels in First Trimester Pregnancies With Gestational Diabetes Mellitus
This study includes pregnancies in 11 to 14 th gestational weeks. Investigators will sample maternal plasma in the first trimester and analyze maternal plasma afamin values. All these women will then be screened by two step OGTT. Investigators will compare afamin levels in GDM and control groups.
Read the detailed description
Background Gestational diabetes mellitus (GDM) is an endocrinopathy that occurs during pregnancy, and presents several clinical findings together with increased blood glucose levels. The frequency of GDM differs, while the incidence of the disease in Turkey is reported to be 7%. Most of the societies recommend screening all women with or without any risk factors in terms of GDM. The definitive diagnosis is made via oral glucose challenge test (OGTT). Early diagnosis and treatment are the key points to improve maternal and fetal outcomes. Different biomarkers are studied regarding GDM diagnosis starting from first trimester. However, there is not a worldwide accepted biomarker for defining the high risk group to the date. Afamin is known as an important indicator of oxidative stress. Moreover, oxidative stress itself is strongly associated with insulin resistance and obesity which are responsible from GDM pathogenesis.
Objective To investigate the association between first trimester maternal plasma afamin levels and GDM. Also, investigators aimed to understand the role of afamin for the prediction of GDM in this study.
Methods This is an observational prospective cohort study conducted in Department of Perinatology, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital, University of Health Sciences, Ankara, Turkey. During 11 and 14 weeks of gestational, maternal blood will be obtained from eligible pregnant women, and samples will be stored at -80 oC. Informed written consent will be obtained from participants. Between 24th and 28th gestational weeks, all these women will be screened by two step OGTT. Then, afamin levels will be compared in GDM and control groups. Exclusion criteria are; multiple pregnancy, fetal anomalies, pregestational diabetes, underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders), age <18 or > 35 years, fasting glucose level > 105 mg/dL or random glucose level > 200 mg/dL.
- Being tested
- Afamin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfaminDiagnostic test
Plasma maternal afamin levels
| Study group | Role | What they receive |
|---|---|---|
| Gestational diabetes mellitus | First trimester pregnancies with gestational diabetes mellitus Receives: Diagnostic Test: Afamin | |
| Control | First trimester healthy pregnancies Receives: Diagnostic Test: Afamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal plasma afamin levels In first trimester GDM prediction
The predictive value of first trimester maternal plasma afamin levels for the diagnosis of gestational diabetes mellitus in comparison with two step OGTT
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Sep 2019
- Primary completion1 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University
- Responsible party
- Principal investigator, Aykan Yucel, Professor, M.D., Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054843
- Sponsor's protocol ID
- Afamin in GDM
- Status last verified
- Dec 2020
- First submitted
- 9 Aug 2019
- Last updated
- 16 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Afamin Levels in First Trimester Pregnancies With Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04054843
- Acronym / sponsor ID
- Afamin in GDM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Etlik Zubeyde Hanım Women's Health Care, Training and Research HospitalUniversity, hospital or other
- Collaborators
- Ankara University
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 13 Aug 2019 (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.
This study includes pregnancies in 11 to 14 th gestational weeks. Investigators will sample maternal plasma in the first trimester and analyze maternal plasma afamin values. All these women will then be screened by two step OGTT. Investigators will compare afamin levels in GDM and control groups.
Detailed description
Background Gestational diabetes mellitus (GDM) is an endocrinopathy that occurs during pregnancy, and presents several clinical findings together with increased blood glucose levels. The frequency of GDM differs, while the incidence of the disease in Turkey is reported to be 7%. Most of the societies recommend screening all women with or without any risk factors in terms of GDM. The definitive diagnosis is made via oral glucose challenge test (OGTT). Early diagnosis and treatment are the key points to improve maternal and fetal outcomes. Different biomarkers are studied regarding GDM diagnosis starting from first trimester. However, there is not a worldwide accepted biomarker for defining the high risk group to the date. Afamin is known as an important indicator of oxidative stress. Moreover, oxidative stress itself is strongly associated with insulin resistance and obesity which are responsible from GDM pathogenesis.
Objective To investigate the association between first trimester maternal plasma afamin levels and GDM. Also, investigators aimed to understand the role of afamin for the prediction of GDM in this study.
Methods This is an observational prospective cohort study conducted in Department of Perinatology, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital, University of Health Sciences, Ankara, Turkey. During 11 and 14 weeks of gestational, maternal blood will be obtained from eligible pregnant women, and samples will be stored at -80 oC. Informed written consent will be obtained from participants. Between 24th and 28th gestational weeks, all these women will be screened by two step OGTT. Then, afamin levels will be compared in GDM and control groups. Exclusion criteria are; multiple pregnancy, fetal anomalies, pregestational diabetes, underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders), age <18 or > 35 years, fasting glucose level > 105 mg/dL or random glucose level > 200 mg/dL.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gestational diabetes mellitus | – | Diagnostic Test: AfaminFirst trimester pregnancies with gestational diabetes mellitus |
| Control | – | Diagnostic Test: AfaminFirst trimester healthy pregnancies |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women within 11 and 14 weeks of gestational weeks
Key inclusion criteria (6 listed)
- singleton pregnancy,
- having no fetal anomalies
- having no pregestational diabetes
- having no underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders)
- age >18 or < 35 years
Key exclusion criteria (6 listed)
- multiple pregnancy
- fetal anomalies
- pregestational diabetes
- underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders)
- age <18 or > 35 years
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 |
|---|---|---|
| AfaminPlasma maternal afamin levels | Diagnostic test | Control, Gestational diabetes mellitus |
Primary outcome
Maternal plasma afamin levels In first trimester GDM prediction
Time frame: 6 months
The predictive value of first trimester maternal plasma afamin levels for the diagnosis of gestational diabetes mellitus in comparison with two step OGTT
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 16 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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 Mellitus in Pregnancy, run by Etlik Zubeyde Hanım Women's Health Care, 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 6 inclusion and 6 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 16 Dec 2020. 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?
Maternal plasma afamin levels In first trimester GDM prediction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2020.