Gestational DiabetesNCT04238936
GDM Patients and Serum Amyloid A and Interleukin-1 (IL-1) Receptor Antagonist
An observational study of Gestational Diabetes, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Serum amyloid A values and Interleukin-1 (IL-1) receptor antagonist values (A-SAA and IL-1Ra)
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2020to 20 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- any infection
- Any known fetal chromosomal or structural anomaly
- Preterm membrane rupture
- Preterm delivery
- Preeclampsia or eclampsia
- Placenta previa
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Süleyman Training and Research Hospital
Istanbul, 33404
About this study
Official title: 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).
- Conditions
- Gestational Diabetes
- Being tested
- Serum amyloid A values, Interleukin-1 (IL-1) receptor antagonist values (A-SAA and IL-1Ra)
- Keywords
- Gestational Diabetes, Serum amyloid A, Interleukin-1 (IL-1) receptor antagonist
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum amyloid A valuesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Serum amyloid A values |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start20 Jan 2020
- Primary completion20 May 2020
- Study completion20 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Kadirogulları, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238936
- Sponsor's protocol ID
- ATADEK-2020/02
- Status last verified
- May 2020
- First submitted
- 20 Jan 2020
- Last updated
- 22 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levels of New Inflammatory Markers in GDM Patients; Serum Amyloid A and Interleukin-1 (IL-1) Receptor Antagonist
- ClinicalTrials.gov ID
- NCT04238936
- Acronym / sponsor ID
- ATADEK-2020/02
- Conditions
- Gestational Diabetes
- Keywords
- Gestational Diabetes, Serum amyloid A, Interleukin-1 (IL-1) receptor antagonist
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 20 May 2020 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group ; Patients with gestational diabetes | – | Diagnostic Test: Serum amyloid A values, 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 | – | Diagnostic Test: Serum amyloid A valuesWomen 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. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- any infection
- Any known fetal chromosomal or structural anomaly
- Preterm membrane rupture
- Preterm delivery
- Preeclampsia or eclampsia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum amyloid A valuesWomen 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 | control group ; healthy pregnant women, study group ; Patients with gestational diabetes |
| 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. | Diagnostic test | study group ; Patients with gestational diabetes |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum amyloid A (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2020.