CClinicalTrials.gg
CompletedNCT04238936Updated May 22, 2020

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

An observational study in Gestational Diabetes, sponsored by Kanuni Sultan Suleyman Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-22.

Sponsored by Kanuni Sultan Suleyman Training and Research Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
18 Years to 42 Years
Sex
Female
01

Study 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).

02

Conditions studied

  • Gestational Diabetes

Browse trials for

Keywords

  • Gestational Diabetes
  • Serum amyloid A
  • Interleukin-1 (IL-1) receptor antagonist
03

In context

Diabetes, Gestational

842 studies on the registry are indexed under Diabetes, Gestational; 198 are open to participants now.

This study's enrollment of 80 is below the median of 200 across 269 observational studies indexed under Diabetes, Gestational.

Browse Diabetes, Gestational studies →

Lead sponsor

Kanuni Sultan Suleyman Training and Research Hospital is the lead sponsor of 216 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
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.

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

Exclusion Criteria:

  • any infection
  • Any known fetal chromosomal or structural anomaly
  • Preterm membrane rupture
  • Preterm delivery
  • Preeclampsia or eclampsia
  • Placenta previa
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (actual)
Patient registry
No

Groups and cohorts

  • 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 · Diagnostic Test: Interleukin-1 (IL-1) receptor antagonist values (A-SAA and IL-1Ra)

  • 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

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 week

  2. 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.

    Time frame: 1 week

07

Study locations

1 site
  • Kanuni Sultan Süleyman Training and Research Hospital
    Istanbul, 33404, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04238936
Lead sponsor
Kanuni Sultan Suleyman Training and Research Hospital
Responsible party
Pınar Kadirogulları (principal investigator, Pınar kadirogullari, M.D, Department of Obstetrics and Gynecology, Kanuni Sultan Suleyman Training and Research Hospital) — Principal investigator
First posted
Jan 23, 2020
Start date
Jan 20, 2020
Primary completion
May 20, 2020
Completion
May 20, 2020
Last update
May 22, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion