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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04238936
Enrollment
80
Registered
2020-01-23
Start date
2020-01-20
Completion date
2020-05-20
Last updated
2020-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Keywords

Gestational Diabetes, Serum amyloid A, Interleukin-1 (IL-1) receptor antagonist

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).

Interventions

DIAGNOSTIC_TESTSerum 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.

DIAGNOSTIC_TESTInterleukin-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.

Sponsors

Kanuni Sultan Suleyman Training and Research Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Serum amyloid A1 weekIts 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 antagonist1 weekIts level will be checked in the study group consisting of pregnant women with GDM and in the control group consisting of healthy pregnant women.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026