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

Gestational Diabetes Clinical Trial

Official title:

Levels of New Inflammatory Markers in GDM Patients; Serum Amyloid A and Interleukin-1 (IL-1) Receptor Antagonist

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04238936
• Other study ID #: ATADEK-2020/02
• Status: Completed
• Start date: January 20, 2020
• Est. completion date: May 20, 2020

Study information

• Verified date: May 2020
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 20, 2020
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Diagnostic Test:
• 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.
• 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.

Locations

Country	Name	City	State
Turkey	Kanuni Sultan Süleyman Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum amyloid A	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.	1 week
Primary	Interleukin-1 (IL-1) receptor antagonist	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.	1 week