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

Completed

• Conditions: Gestational Diabetes
• Interventions: Diagnostic Test: Serum amyloid A values; Diagnostic Test: Interleukin-1 (IL-1) receptor antagonist values (A-SAA and IL-1Ra)

• Registration Number: NCT04238936
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2020-01-20
• Study First Submitted: 2020-01-20
• Study First Submitted QC: 2020-01-20
• Study First Posted: 2020-01-23
• Status Verified: 2020-05
• Primary Completion: 2020-05-20
• Study Completion: 2020-05-20
• Last Update Submitted: 2020-05-21
• Last Update Posted: 2020-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

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Exclusion Criteria

• any infection
• Any known fetal chromosomal or structural anomaly
• Preterm membrane rupture
• Preterm delivery
• Preeclampsia or eclampsia
• Placenta previa

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study group ; Patients with gestational diabetes	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.
control group ; healthy pregnant women	Serum amyloid A values	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.
study group ; Patients with gestational diabetes	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.

Primary Outcome Measures

Name	Time	Method
Serum amyloid A	1 week	Its level will be checked in the study group consisting of pregnant women with GDM and in the control group consisting of healthy pregnant women.
Interleukin-1 (IL-1) receptor antagonist	1 week	Its level will be checked in the study group consisting of pregnant women with GDM and in the control group consisting of healthy pregnant women.

Trial Locations

Locations (1)

Kanuni Sultan Süleyman Training and Research Hospital; 🇹🇷 Istanbul, Turkey