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Completed

NCT Number: NCT04238936

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

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).

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum amyloid A values

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)

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.

Primary outcomes

  1. Serum amyloid A

    Time frame: 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.

  2. Interleukin-1 (IL-1) receptor antagonist

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 23, 2020
Registry last updated
May 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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