ClinicalTrials.gg
Status unknownNCT05591664Updated Oct 24, 2022

Eicosapentaenoic Acid Serum Levels in Patients With Gestational Diabetes

An observational study in Gestational Diabetes, sponsored by Recep Tayyip Erdogan University Training and Research Hospital. Status unknown. Open to female participants aged 18 Years to 46 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-10-24.

Sponsored by Recep Tayyip Erdogan University Training and Research Hospital · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
118
Ages
18 Years to 46 Years
Sex
Female
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Study 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 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.

02

Conditions studied

  • Gestational Diabetes

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Keywords

  • gestational diabetes
  • Eikosapentaenoik acid
  • fatty acids
  • omega-3
03

In context

Diabetes, Gestational

857 studies on the registry are indexed under Diabetes, Gestational; 199 are open to participants now.

This study's planned enrollment of 118 is below the median of 198 across 274 observational studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Recep Tayyip Erdogan University Training and Research Hospital is the lead sponsor of 88 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 46 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Eligibility criteria

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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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
118 participants (estimated)
Patient registry
No

Groups and cohorts

  • GROUP 1

    There will be 38 patients diagnosed with gestational diabetes in the study group.

    Diagnostic Test: eicosapentaenoic acid

  • GROUP 2

    There will be 80 normal pregnant women in the control group

    Diagnostic Test: eicosapentaenoic acid

Interventions

  • Diagnostic testeicosapentaenoic acid

    eicosapentaenoic acid levels of the groups will be monitored

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What researchers measure

Primary outcomes

  1. eicosapentaenoic acid

    eicosapentaenoic acid levels between groups will be measured

    Time frame: 6 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2022; primary completion for Apr 2023, 6 months later.

Of 133 non-industry observational studies under Diabetes, Gestational, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 70. This study's planned 6 months is below that.

Counting every sponsor, half of 135 studies reached it within 42 months; a quarter within 23 and three quarters within 70.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 19, 2022
First posted
Oct 24, 2022
StartEst.
Oct 17, 2022
Primary completionEst.
Apr 30, 2023
CompletionEst.
May 30, 2023
Last update
Oct 24, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05591664
Lead sponsor
Recep Tayyip Erdogan University Training and Research Hospital
Responsible party
Senol Senturk (Associate professor, Recep Tayyip Erdogan University Training and Research Hospital) — Principal investigator
First posted
Oct 24, 2022
Start date
Oct 17, 2022 (estimated)
Primary completion
Apr 30, 2023 (estimated)
Completion
May 30, 2023 (estimated)
Last update
Oct 24, 2022

Study contacts

SENOL SENTURK
Contact
dr.senturk@hotmail.com
+905327166482
SENOL SENTURK
study director · Recep Tayyip Erdogan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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