- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05463237
Comparison of Visceral Adipokines Visfatin, Vaspin and Omentin Levels in Gestational Diabetes Mellitus Pregnant Women
August 24, 2023 updated by: Serif Aksin, Siirt University
The Relation Between Visceral Adipokines Gestational Diabetes Mellitus
The prevalence of maternal obesity is increasing rapidly worldwide and constitutes an important obstetric problem that increases mortality and morbidity in both mothers and infants.
Obese women are prone to pregnancy complications such as gestational diabetes mellitus (GDM), and children of obese mothers are more likely to develop cardiovascular and metabolic disease later in life.
The risk of developing GDM in obese pregnants is 1.3-3.8
times higher than in pregnant women with a normal body mass index, and approximately 70% of women with GDM remain at risk of developing type 2 diabetes until 28 years postpartum.
Gestational diabetes mellitus (GDM) affects approximately 6% of pregnant women and its prevalence is increasing in parallel with the obesity epidemic.
GDM is associated with an increased risk of adverse pregnancy outcomes, including macrosomia, preterm delivery, neonatal hypoglycemia, neonatal jaundice, and congenital anomalies.
It is also associated with a higher incidence of type 2 diabetes mellitus after birth.
It is known that visceral adipose tissue increases in obese women.
It is thought that there is a relationship between visceral adipose tissue increase and diabetes.
In this study, the levels of new adipocytokines such as Visfatin, Vaspin and Omentin secreted from visceral adipose tissue in patients diagnosed with GDM will be measured.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The investigators aim in this study the levels of Visfatin, Vaspin and Omentin secreted from this tissue in pregnant women diagnosed with GDM by oral glucose tolerance test (OGTT) between 24-28 weeks of gestation and to determine if there is a relationship between these parameters.
For this purpose, , and 87 pregnant women with gestational diabetes diagnosed at 24-28 weeks from the same patient group will be included in the study. .
The same number of non-GDM control group pregnant women will also be included in the study at 24-28 weeks.
Age, gestational week, pregnancy history (gravida, parity, abortion, missed, ectopic), medical history, preconceptional BMI, current BMI, triglyceride, VLDL, HDL, LDL, cholesterol, HOMA-IR, C-peptide, insulin, Hba1c levels will be saved.
In the 2nd trimester, between 24-26 weeks, OGTT will be performed on the patients and the results will be recorded.
Visfatin, Vaspin and Omentin levels will be checked and recorded in patients diagnosed with GDM.
Study Type
Observational
Enrollment (Actual)
174
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
-
-
-
Siirt, Turkey, 56000
- Siirt Üniversity Medical Faculty
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
Pregnant women over the age of 18 who are in the first trimester of pregnancy and are not diagnosed with diabetes
Description
Inclusion Criteria:
- >18 years of age
- At the 2.st trimester of pregnancy
Exclusion Criteria:
- History of with diabetes mellitus
- Morbidly obese pregnants
- History of abdomen liposuction
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pregnant women with gestational diabetes(n:87)
Visceral adipokine level will be examined in pregnant women with gestational diabetes.
|
oral glucose tolerance test (OGTT) used for the diagnosis of gestational diabetes mellitus between 24-28 weeks of gestation
Measurement of blood Visfatin, Vaspin and Omentin levels in pregnant women with diabetes
|
Control group pregnant (n:87)
Visceral adipokine level will be examined in pregnant women with normal pregnant .
|
oral glucose tolerance test (OGTT) used for the diagnosis of gestational diabetes mellitus between 24-28 weeks of gestation
Measurement of blood Visfatin, Vaspin and Omentin levels in pregnant women with diabetes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
24-28. Visceral Adipokine Levels in Pregnant Women with Gestational Diabetes Between Weeks
Time Frame: Between 24-28 weeks of pregnancy, (an average of 6 months)
|
VASPIN, VISFATIN, OMENTIN levels will be measured in patients with gestational diabetic,
|
Between 24-28 weeks of pregnancy, (an average of 6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Şerif Aksin, Siirt Üniversity Medical Faculty Obstetrics and Gynecology Department
- Study Director: Şerif Aksin, Assoc.Prof, Siirt University Medical Faculty Obstetrics and Gynecology Departmant
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)
October 31, 2022
Primary Completion (Actual)
August 25, 2023
Study Completion (Actual)
August 25, 2023
Study Registration Dates
First Submitted
June 30, 2022
First Submitted That Met QC Criteria
July 14, 2022
First Posted (Actual)
July 18, 2022
Study Record Updates
Last Update Posted (Actual)
August 28, 2023
Last Update Submitted That Met QC Criteria
August 24, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SiirtUNI
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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