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

May 21, 2020 updated by: Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital

Levels of New Inflammatory Markers in GDM Patients; 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 33404
        • Kanuni Sultan Suleyman Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Serum amyloid A (SAA) and Interleukin-1 (IL-1) receptor antagonist level will be examined in the study group consisting of pregnant women with GDM diagnosis and in the control group consisting of healthy pregnant women.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week
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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2020

Primary Completion (ACTUAL)

May 20, 2020

Study Completion (ACTUAL)

May 20, 2020

Study Registration Dates

First Submitted

January 20, 2020

First Submitted That Met QC Criteria

January 20, 2020

First Posted (ACTUAL)

January 23, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 22, 2020

Last Update Submitted That Met QC Criteria

May 21, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATADEK-2020/02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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