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Gestational DiabetesNCT05591664

Eicosapentaenoic Acid Serum Levels in Patients With Gestational Diabetes

An observational study of Gestational Diabetes, run by Recep Tayyip Erdogan University Training and Research Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

In this study, we aim to compare the blood levels of Eicosapentaenoic acid (EPA) in gestational diabetes patients with normal pregnant women, to reveal the relationship between these markers, which are known to be effective on metabolic function, and gestational diabetes, and to contribute to future studies and… Read more about this study

Who is it for?
Ages 18 to 46 years, women onlyHealthy volunteers can take part
Conditions the study is for
Gestational Diabetes
What is being tested?
eicosapentaenoic acid
How many people
118 participants
Where
No sites listed yet
Study dates
17 Oct 2022to 30 May 2023
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 46 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: 18-46 years old pregnant women at 24-28 weeks of gestation with and without gestational mellitus (study and control)

Inclusion Criteria: 18-46 years old pregnant women at 24-28 weeks of gestation -

Exclusion Criteria: For each group; Pregnant women under 18 or over 46 years of age, multiple pregnancies, stillbirth, presence of preeclampsia, pregestational diabetes mellitus, hypertension, history of congenital cardiopathy, presence of serious systemic disorders such as chronic liver and kidney diseases, active smoking, being a smoker will be determined

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Trial locations and contacts

No sites are listed yet.

About this study

Official title: Comparison of Eicosapentaenoic Acid Serum Levels in Patients With Gestational Diabetes and Control Group

In this study, we aim to compare the blood levels of Eicosapentaenoic acid (EPA) in gestational diabetes patients with normal pregnant women, to reveal the relationship between these markers, which are known to be effective on metabolic function, and gestational diabetes, and to contribute to future studies and possible treatment options.

Read the detailed description

The research is a prospective cross-sectional study to be conducted at Recep Tayyip Erdogan University Training and Research Hospital, Department of Obstetrics and Gynecology. The current treatments of the patients will not be changed and no medical treatment or interventional procedures will be applied to the patients for study purposes. After the patients are informed about the study, their signatures will be taken on the consent form stating that they voluntarily participated in the study. Apart from the biochemical parameters required for the diagnosis and treatment of the patients, different parameters will not be considered. The supply of Eicosapentaenoic acid (EPA) kits required for the study will be provided by the executive physician and the blood taken from the patients will be evaluated.

G * Power 3.1.9.7 program was used to calculate the sample size for this study. At 80% statistical power and α=0.05 significance level, the smallest required sample size was calculated as 110 (control :75- study :35) when d=0.51 effect size was calculated according to t-test for independent groups. Considering that there may be missing data, 118 women between the ages of 18-46 will be included in the study. There will be 38 patients diagnosed with gestational diabetes in the study group. There will be 80 normal pregnant women in the control group. The diagnosis of GDM cases will be determined by 75 g oral glucose tolerance test (OGTT) performed between 24 and 28 weeks of gestation. According to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) criteria, pregnant women will be considered to have GDM if one of the following plasma glucose values is met or exceeded: 0.st ≥92 mg/dl; 1st hour ≥180 mg/dl; 2nd hour ≥153 mg/dl.

Demographic, clinical and laboratory data of the pregnant women included in the study, age, number of previous live-stillbirths, previou type of delivery, gestational weeks, complete blood count for each patient. Detailed anamnesis, including information such as family history of diabetes, will be recorded. The last menstrual period, obstetric examination and ultrasonography findings will be taken as basis in the determination of the gestational week.

Inclusion criteria of patients in the study: 18-46 years old pregnant women at 24-28. gestational weeks Exclusion criteria of the patients in the study: For each group; Pregnant women under 18-46 years of age, multiple pregnancies, stillbirth, presence of preeclampsia, pregestational diabetes mellitus, hypertension, history of congenital cardiopathy, presence of serious systemic disorders such as chronic liver and kidney diseases, active smoking, being a smoker will be determined.

Since the medical treatment of the patients was not changed and additional medical treatment and interventional procedures were not applied in the study, it would not be necessary to take safety precautions. The blood taken from the patients for routine diagnosis and treatment will be stored at -20 degrees Celsius after the serum and plasma are separated. By comparing the blood levels of Eicosapentaenoic acid (EPA) in gestational diabetes patients with normal pregnant women, the relationship between these markers, which are known to be effective on metabolic function, and gestational diabetes will be evaluated. Afterwards, follow-up, treatment and laboratory evaluation for study purposes are not required.

Being tested
eicosapentaenoic acid
Keywords
gestational diabetes, Eikosapentaenoik acid, fatty acids, omega-3
Medical subject headings
Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eicosapentaenoic acidDiagnostic test

    eicosapentaenoic acid levels of the groups will be monitored

Study groups in NCT05591664
Study groupRoleWhat they receive
GROUP 1There will be 38 patients diagnosed with gestational diabetes in the study group.
Receives: Diagnostic Test: eicosapentaenoic acid
GROUP 2There will be 80 normal pregnant women in the control group
Receives: Diagnostic Test: eicosapentaenoic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. eicosapentaenoic acid

    eicosapentaenoic acid levels between groups will be measured

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2022
  2. Study start17 Oct 2022 (estimated)
  3. Primary completion30 Apr 2023 (estimated)
  4. Study completion30 May 2023 (estimated)

Resources

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
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05591664
Sponsor's protocol ID
2022/170
Status last verified
Oct 2022
First submitted
19 Oct 2022
Last updated
24 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Gestational Diabetes, run by Recep Tayyip Erdogan University Training and Research Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact SENOL SENTURK (+905327166482, dr.senturk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

eicosapentaenoic acid (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 24 Oct 2022.

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