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.
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
-
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.
- Conditions
- Gestational Diabetes
- 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 group | Role | What they receive |
|---|---|---|
| GROUP 1 | There will be 38 patients diagnosed with gestational diabetes in the study group. Receives: Diagnostic Test: eicosapentaenoic acid | |
| GROUP 2 | There 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.
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.
- First posted24 Oct 2022
- Study start17 Oct 2022 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion30 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senol Senturk, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- SENOL SENTURK, Study director, Recep Tayyip Erdogan University
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Eicosapentaenoic Acid Serum Levels in Patients With Gestational Diabetes and Control Group
- ClinicalTrials.gov ID
- NCT05591664
- Acronym / sponsor ID
- 2022/170
- Conditions
- Gestational Diabetes
- Keywords
- gestational diabetes, Eikosapentaenoik acid, fatty acids, omega-3
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 17 Oct 2022 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 May 2023 (estimated)
- First posted
- 24 Oct 2022 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP 1 | – | Diagnostic Test: eicosapentaenoic acidThere will be 38 patients diagnosed with gestational diabetes in the study group. |
| GROUP 2 | – | Diagnostic Test: eicosapentaenoic acidThere will be 80 normal pregnant women in the control group |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 18-46 years old pregnant women at 24-28 weeks of gestation with and without gestational mellitus (study and control)
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 |
|---|---|---|
| eicosapentaenoic acideicosapentaenoic acid levels of the groups will be monitored | Diagnostic test | GROUP 1, GROUP 2 |
Primary outcome
eicosapentaenoic acid
Time frame: 6 months
eicosapentaenoic acid levels between groups will be measured
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
SENOL SENTURK study director
Recep Tayyip Erdogan University
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.