Serum Endocan Levels and Gestational Diabetes
Primary Purpose
Gestational Diabetes, Endocan
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Serum Endocan Levels
Sponsored by
About this trial
This is an interventional diagnostic trial for Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:
- being pregnant at 24-26 weeks of gestation
- having oral glucose toleranse screening test
- age between 18-45 years
Exclusion Criteria:
- 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
Sites / Locations
- Gaziosmanpaşa Treh
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients with Gestational Diabetes
Healty Pregnants
Arm Description
pregnant women who are at 24-26 weeks of gestational age with positive oral glucose tolerance screening test.
pregnant women who are at 24-26 weeks of gestational age with normal oral glucose tolerance screening test.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05237895
First Posted
February 3, 2022
Last Updated
August 3, 2022
Sponsor
Gaziosmanpasa Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05237895
Brief Title
Serum Endocan Levels and Gestational Diabetes
Official Title
Evaluation of Serum Endocan Levels in Patients With Gestational Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 3, 2022 (Actual)
Primary Completion Date
May 5, 2022 (Actual)
Study Completion Date
May 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Endocan
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with Gestational Diabetes
Arm Type
Other
Arm Description
pregnant women who are at 24-26 weeks of gestational age with positive oral glucose tolerance screening test.
Arm Title
Healty Pregnants
Arm Type
Other
Arm Description
pregnant women who are at 24-26 weeks of gestational age with normal oral glucose tolerance screening test.
Intervention Type
Diagnostic Test
Intervention Name(s)
Serum Endocan Levels
Intervention Description
Detection of Serum Endocan Levels and detection of possible diagnostic association with gestational diabetes
Primary Outcome Measure Information:
Title
Detection of diagnostic value of serum endocan levels in patient with gestational diabetes
Description
Identifying diagnostic value of serum endocan by comparing serum levels of endocan in groups.
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
being pregnant at 24-26 weeks of gestation
having oral glucose toleranse screening test
age between 18-45 years
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
elif yıldız, MD
Organizational Affiliation
Gaziosmanpasa Research and Education Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaziosmanpaşa Treh
City
Istanbul
State/Province
Gaziosmanpaşa
ZIP/Postal Code
34000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Serum Endocan Levels and Gestational Diabetes
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