Gestational DiabetesNCT04585204
Comparison of the Detection Rates of 50 Gr-100 Gr OGTT and 75 Gr OGTT That Require Medical Treatment of GDM
A study testing Oral glucose tolerance test in people with Gestational Diabetes and Glucose Intolerance During Pregnancy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Both 50 gr OGTT-100 gr OGTT and 75 gr OGTT are used for detecting gestational diabetes mellitus. Two approaches are approved by obstetricians. With this study, we aim to compare the gestational diabetes mellitus detection rate of these different tests. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Glucose Intolerance During Pregnancy
- What is being tested?
- Oral glucose tolerance test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,282 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2020to 1 Dec 2024
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women
Who cannot join
- Already diagnosed by diabetes mellitus
- Multiple pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara City Hospital
Ankara
Seval Erdinç, 00905054884144, sevalerdinc@gmail.com
About this study
Both 50 gr OGTT-100 gr OGTT and 75 gr OGTT are used for detecting gestational diabetes mellitus. Two approaches are approved by obstetricians. With this study, we aim to compare the gestational diabetes mellitus detection rate of these different tests.
- Being tested
- Oral glucose tolerance test
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose tolerance testDiagnostic test
Oral glucose tolerance test
| Study group | Role | What they receive |
|---|---|---|
| 50 gr-100 gr OGTT | Active comparator | patients are tested firstly by 50 gr OGTT after that if necessary by 100 gr OGTT Receives: Diagnostic Test: Oral glucose tolerance test |
| 75 gr OGTT | Active comparator | patients are tested by 75 gr OGTT Receives: Diagnostic Test: Oral glucose tolerance test |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference of GDM detection rate of 50 gr- 100 gr OGTT and 75 gr OGTT
to determine the ideal diagnostic test
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Oct 2020
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe 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
- 2,282 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585204
- Sponsor's protocol ID
- E1-20-800
- Status last verified
- Jul 2024
- First submitted
- 9 Oct 2020
- Last updated
- 15 Aug 2024
- 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 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Detection Rates of 50 Gr-100 Gr OGTT and 75 Gr OGTT That Require Medical Treatment of GDM
- ClinicalTrials.gov ID
- NCT04585204
- Acronym / sponsor ID
- E1-20-800
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,282 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 14 Oct 2020 (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.
Both 50 gr OGTT-100 gr OGTT and 75 gr OGTT are used for detecting gestational diabetes mellitus. Two approaches are approved by obstetricians. With this study, we aim to compare the gestational diabetes mellitus detection rate of these different tests.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 gr-100 gr OGTT | Active comparator | Diagnostic Test: Oral glucose tolerance testpatients are tested firstly by 50 gr OGTT after that if necessary by 100 gr OGTT |
| 75 gr OGTT | Active comparator | Diagnostic Test: Oral glucose tolerance testpatients are tested by 75 gr OGTT |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant women
Key exclusion criteria (2 listed)
- Already diagnosed by diabetes mellitus
- Multiple 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 |
|---|---|---|
| Oral glucose tolerance testOral glucose tolerance test | Diagnostic test | 50 gr-100 gr OGTT, 75 gr OGTT |
Primary outcome
the difference of GDM detection rate of 50 gr- 100 gr OGTT and 75 gr OGTT
Time frame: one year
to determine the ideal diagnostic test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral glucose tolerance test in people with Gestational Diabetes and Glucose Intolerance During Pregnancy, run by Ankara City Hospital Bilkent 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Aug 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the difference of GDM detection rate of 50 gr- 100 gr OGTT and 75 gr OGTT (time frame: one year). 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 15 Aug 2024.