GDM Patients and Serum Amyloid A and Interleukin-1 (IL-1) Receptor Antagonist

NCT ID: NCT04238936

Last Updated: 2020-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-20

Study Completion Date

2020-05-20

Brief Summary

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Serum amyloid A and Interleukin-1 (IL-1) receptor antagonist (A-SAA and IL-1Ra) values;

* Comparison of pregnant women with and without GDM diagnosis
* Comparison of insulin therapy and diet-regulated GDM patients
* Comparison of pregnant women with and without LGA (large gestational age)
* Comparison of pregnant women with and without polyhydroamnios
* Investigation of its effect on pregnancy prognosis
* In the prediction of GDM diagnosis, it is aimed to study the sensitivity and specificity of both parameters and cut off values.

(In GDM patients, liver and kidney function parameters will also be evaluated with A-SAA and IL-1Ra levels).

Detailed Description

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Conditions

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Gestational Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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study group ; Patients with gestational diabetes

Women who are diagnosed with GDM between the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.

Serum amyloid A values

Intervention Type DIAGNOSTIC_TEST

Women who are diagnosed with GDM between the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.

Interleukin-1 (IL-1) receptor antagonist values (A-SAA and IL-1Ra)

Intervention Type DIAGNOSTIC_TEST

Women who are diagnosed with GDM between the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.

control group ; healthy pregnant women

Women who are healthy pregnant women, the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.

Serum amyloid A values

Intervention Type DIAGNOSTIC_TEST

Women who are diagnosed with GDM between the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.

Interventions

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Serum amyloid A values

Women who are diagnosed with GDM between the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.

Intervention Type DIAGNOSTIC_TEST

Interleukin-1 (IL-1) receptor antagonist values (A-SAA and IL-1Ra)

Women who are diagnosed with GDM between the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with 50 gr OGTT + 100 gr OGTT + at 24-28 weeks of gestation
* Patients with 75 gr OGTT + at 24-28 weeks of gestation
* 18-42 years pregnant women

Exclusion Criteria

* any infection
* Any known fetal chromosomal or structural anomaly
* Preterm membrane rupture
* Preterm delivery
* Preeclampsia or eclampsia
* Placenta previa
Minimum Eligible Age

18 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Pınar Kadirogulları

principal investigator, Pınar kadirogullari, M.D, Department of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ATADEK-2020/02

Identifier Type: -

Identifier Source: org_study_id

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