Gestational DiabetesNCT05237895
Serum Endocan Levels and Gestational Diabetes
A study testing Serum Endocan Levels in people with Gestational Diabetes and Endocan, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
In diabetic patients, serum endocan level has been significantly increased in patients and the levels on the long-term complications are correlated. Based on the Iinformation obtained from these studies, it can be said that there is a strong association between diabetes and serum endocan levels. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes, Endocan
- What is being tested?
- Serum Endocan Levels
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Mar 2022to 5 May 2022
- Phase
- Interventional
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- being pregnant at 24-26 weeks of gestation
- having oral glucose toleranse screening test
- age between 18-45 years
Who cannot join
- having in utero mort fetus
- having a previous diagnosis of diabetes
- having a multiple pregnancy
- having a coronary artery disease
- having preeclampcia
- having a pregnancy obtained by assisted reproductive technology
- using cigarette
- using alcohol
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziosmanpaşa Treh
Istanbul, Gaziosmanpaşa, 34000
About this study
Official title: Evaluation of Serum Endocan Levels in Patients With Gestational Diabetes
In diabetic patients, serum endocan level has been significantly increased in patients and the levels on the long-term complications are correlated. Based on the Iinformation obtained from these studies, it can be said that there is a strong association between diabetes and serum endocan levels.
Read the detailed description
It has been shown that endocan level of plasental tissue in gestational diabtes patients is significantly increased when looking at the same week compared with plasenta tissue samples of helathy pregnancy. From the information obtained from these studies, it can be said that there is a strong association between diabetes mellitus and serum endocan levels. investigators aimed to determine the relationship between serum endocan levels and gestational diabetes in the study.
- Conditions
- Gestational Diabetes, Endocan
- Being tested
- Serum Endocan Levels
- 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 Endocan LevelsDiagnostic test
Detection of Serum Endocan Levels and detection of possible diagnostic association with gestational diabetes
| Study group | Role | What they receive |
|---|---|---|
| Patients with Gestational Diabetes | Other | pregnant women who are at 24-26 weeks of gestational age with positive oral glucose tolerance screening test. Receives: Diagnostic Test: Serum Endocan Levels |
| Healty Pregnants | Other | pregnant women who are at 24-26 weeks of gestational age with normal oral glucose tolerance screening test. Receives: Diagnostic Test: Serum Endocan Levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of diagnostic value of serum endocan levels in patient with gestational diabetes
Identifying diagnostic value of serum endocan by comparing serum levels of endocan in groups.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start3 Mar 2022
- Primary completion5 May 2022
- Study completion5 May 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Elif Yıldız, Gaziosmanpasa Research and Education Hospital
- Investigators
- elif yıldız, MD, Principal investigator, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237895
- Sponsor's protocol ID
- GaziosmanpaşaTREHi
- Status last verified
- Aug 2022
- First submitted
- 3 Feb 2022
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Endocan Levels in Patients With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT05237895
- Acronym / sponsor ID
- GaziosmanpaşaTREHi
- Conditions
- Gestational Diabetes, Endocan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 5 May 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 14 Feb 2022 (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.
In diabetic patients, serum endocan level has been significantly increased in patients and the levels on the long-term complications are correlated. Based on the Iinformation obtained from these studies, it can be said that there is a strong association between diabetes and serum endocan levels.
Detailed description
It has been shown that endocan level of plasental tissue in gestational diabtes patients is significantly increased when looking at the same week compared with plasenta tissue samples of helathy pregnancy. From the information obtained from these studies, it can be said that there is a strong association between diabetes mellitus and serum endocan levels. investigators aimed to determine the relationship between serum endocan levels and gestational diabetes in the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Gestational Diabetes | Other | Diagnostic Test: Serum Endocan Levelspregnant women who are at 24-26 weeks of gestational age with positive oral glucose tolerance screening test. |
| Healty Pregnants | Other | Diagnostic Test: Serum Endocan Levelspregnant women who are at 24-26 weeks of gestational age with normal oral glucose tolerance screening test. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- being pregnant at 24-26 weeks of gestation
- having oral glucose toleranse screening test
- age between 18-45 years
Key exclusion criteria (8 listed)
- having in utero mort fetus
- having a previous diagnosis of diabetes
- having a multiple pregnancy
- having a coronary artery disease
- having preeclampcia
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 Endocan LevelsDetection of Serum Endocan Levels and detection of possible diagnostic association with gestational diabetes | Diagnostic test | Healty Pregnants, Patients with Gestational Diabetes |
Primary outcome
Detection of diagnostic value of serum endocan levels in patient with gestational diabetes
Time frame: 3 months
Identifying diagnostic value of serum endocan by comparing serum levels of endocan in groups.
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 5 Aug 2022.
- Individual participant dataSharing planned: No
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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.
elif yıldız, MD principal investigator
Gaziosmanpasa Research and Education Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum Endocan Levels in people with Gestational Diabetes and Endocan, run by Gaziosmanpasa Research and Education 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 8 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 5 Aug 2022. 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?
Detection of diagnostic value of serum endocan levels in patient with gestational diabetes (time frame: 3 months). 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 5 Aug 2022.