NCT05591664

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
118

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 17, 2022

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 24, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

October 24, 2022

Status Verified

October 1, 2022

Enrollment Period

7 months

First QC Date

October 19, 2022

Last Update Submit

October 19, 2022

Conditions

Gestational Diabetes

Keywords

gestational diabetesEikosapentaenoik acidfatty acidsomega-3

Outcome Measures

Primary Outcomes (1)

  • eicosapentaenoic acid

    eicosapentaenoic acid levels between groups will be measured

    6 months

Study Arms (2)

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

eicosapentaenoic acidDIAGNOSTIC_TEST

eicosapentaenoic acid levels of the groups will be monitored

GROUP 1GROUP 2

Eligibility Criteria

Age18 Years - 46 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • SENOL SENTURK

    Recep Tayyip Erdogan University

    STUDY DIRECTOR

Central Study Contacts

SENOL SENTURK

CONTACT

+905327166482dr.senturk@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 19, 2022

First Posted

October 24, 2022

Study Start

October 17, 2022

Primary Completion

April 30, 2023

Study Completion

May 30, 2023

Last Updated

October 24, 2022

Record last verified: 2022-10