Diabetes MellitusNCT07433465
Early Pregnancy Serum Ferritin Levels as a Predictor for Gestational Diabetes Mellitus
An observational study of Diabetes Mellitus, run by Zagazig University at 1 site in Egypt.
Trial summary
This prospective study evaluates a target population of pregnant women at the time of pregnancy diagnosis to investigate the predictive value of serum ferritin (SF) levels for the later development of gestational diabetes mellitus (GDM). Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Glycemic Markers
- How many people
- 556 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Dec 2022to 10 Oct 2025
- 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 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women at the time of their initial pregnancy diagnosis, typically presenting at prenatal or outpatient clinics.
Who may be able to join
- Confirmed pregnancy at an early gestational age.
- Provision of clinical and family history (e.g., age, BMI, history of GDM).
Who cannot join
- Pre-existing Type 1 or Type 2 Diabetes Mellitus.
- Conditions known to significantly alter iron metabolism independent of pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Serum Ferritin Early in Pregnancy May Predict the Development of Gestational Diabetes Later.
This prospective study evaluates a target population of pregnant women at the time of pregnancy diagnosis to investigate the predictive value of serum ferritin (SF) levels for the later development of gestational diabetes mellitus (GDM). The intervention involves measuring early-pregnancy SF, transferrin, and hemoglobin levels, alongside HbA1c, and comparing these biomarkers between women who later develop GDM and those who remain normoglycemic. The primary outcome is to assess the success rate of this diagnostic regimen in identifying high-risk individuals, aiming to establish SF as a valuable early biomarker for GDM to enable timely interventions.
- Conditions
- Diabetes Mellitus
- Being tested
- Glycemic Markers
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycemic MarkersDiagnostic test
Fasting blood glucose (FBG), 2-h Post postprandial blood glucose (PPBG), HbA1c, and Fasting Serum Insulin (FSI).
| Study group | Role | What they receive |
|---|---|---|
| GDM Group | Pregnant women who develop gestational diabetes mellitus later in pregnancy. Receives: Diagnostic Test: Glycemic Markers | |
| Non GDM Group | Pregnant women who maintain normal glucose tolerance throughout pregnancy. Receives: Diagnostic Test: Glycemic Markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Diagnostic Regimens in Predicting Gestational Diabetes Mellitus
The efficacy of early pregnancy Serum Ferritin (SF) levels in accurately identifying women who will subsequently meet the diagnostic criteria for GDM.
Measured: 24-28 weeks gestation
Secondary outcomes (1)
Iron Homeostasis Markers
Levels of serum transferrin and hemoglobin concentration as indicators of insulin resistance and diabetic risk.
Measured: 24-28 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start5 Dec 2022
- Primary completion7 Dec 2024
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Bassem Mohamed Talaat Abdelaziz Ali, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433465
- Sponsor's protocol ID
- RC:17.11.2022
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Serum Ferritin Early in Pregnancy May Predict the Development of Gestational Diabetes Later.
- ClinicalTrials.gov ID
- NCT07433465
- Acronym / sponsor ID
- RC:17.11.2022
- Conditions
- Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 5 Dec 2022 (actual)
- Primary completion
- 7 Dec 2024 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 25 Feb 2026 (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 prospective study evaluates a target population of pregnant women at the time of pregnancy diagnosis to investigate the predictive value of serum ferritin (SF) levels for the later development of gestational diabetes mellitus (GDM). The intervention involves measuring early-pregnancy SF, transferrin, and hemoglobin levels, alongside HbA1c, and comparing these biomarkers between women who later develop GDM and those who remain normoglycemic. The primary outcome is to assess the success rate of this diagnostic regimen in identifying high-risk individuals, aiming to establish SF as a valuable early biomarker for GDM to enable timely interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDM Group | – | Diagnostic Test: Glycemic MarkersPregnant women who develop gestational diabetes mellitus later in pregnancy. |
| Non GDM Group | – | Diagnostic Test: Glycemic MarkersPregnant women who maintain normal glucose tolerance throughout pregnancy. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women at the time of their initial pregnancy diagnosis, typically presenting at prenatal or outpatient clinics.
Key inclusion criteria (2 listed)
- Confirmed pregnancy at an early gestational age.
- Provision of clinical and family history (e.g., age, BMI, history of GDM).
Key exclusion criteria (2 listed)
- Pre-existing Type 1 or Type 2 Diabetes Mellitus.
- Conditions known to significantly alter iron metabolism independent of 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 |
|---|---|---|
| Glycemic MarkersFasting blood glucose (FBG), 2-h Post postprandial blood glucose (PPBG), HbA1c, and Fasting Serum Insulin (FSI). | Diagnostic test | GDM Group, Non GDM Group |
Primary outcome
Success Rate of Diagnostic Regimens in Predicting Gestational Diabetes Mellitus
Time frame: 24-28 weeks gestation
The efficacy of early pregnancy Serum Ferritin (SF) levels in accurately identifying women who will subsequently meet the diagnostic criteria for GDM.
1 secondary outcome
Iron Homeostasis Markers
Time frame: 24-28 weeks gestation
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 25 Feb 2026.
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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 Diabetes Mellitus, run by Zagazig University at 1 site in Egypt.
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 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: finished, as of the sponsor's last update on 25 Feb 2026. 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 Egypt. 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?
Success Rate of Diagnostic Regimens in Predicting Gestational Diabetes Mellitus (time frame: 24-28 weeks gestation). 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 25 Feb 2026.