Eicosapentaenoic Acid Serum Levels in Patients With Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05591664
• Other study ID #: 2022/170
• Status: Not yet recruiting
• Start date: October 17, 2022
• Est. completion date: May 30, 2023

Study information

• Verified date: October 2022
• Source: Recep Tayyip Erdogan University Training and Research Hospital
• Contact: SENOL SENTURK
• Phone: +905327166482
• Email: dr.senturk[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 possible treatment options.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 118
• Est. completion date: May 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 46 Years

Eligibility

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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Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes

Intervention

Diagnostic Test:
• eicosapentaenoic acid
eicosapentaenoic acid levels of the groups will be monitored

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Recep Tayyip Erdogan University Training and Research Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eicosapentaenoic acid	eicosapentaenoic acid levels between groups will be measured	6 months