Comparison of Visceral Adipokines Visfatin, Vaspin and Omentin Levels in Gestational Diabetes Mellitus Pregnant Women

Obesity Clinical Trial

Official title:

The Relation Between Visceral Adipokines Gestational Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05463237
• Other study ID #: SiirtUNI
• Status: Completed
• Start date: October 31, 2022
• Est. completion date: August 25, 2023

Study information

• Verified date: August 2023
• Source: Siirt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: August 25, 2023
• Est. primary completion date: August 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes
• Obesity
• Obesity, Abdominal
• Visceral Obesity

Intervention

Diagnostic Test:
• oral glucose tolerance test
oral glucose tolerance test (OGTT) used for the diagnosis of gestational diabetes mellitus between 24-28 weeks of gestation
• Blood sample
Measurement of blood Visfatin, Vaspin and Omentin levels in pregnant women with diabetes

Locations

Country	Name	City	State
Turkey	Siirt Üniversity Medical Faculty	Siirt

Sponsors (1)

Lead Sponsor	Collaborator
Siirt University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-28. Visceral Adipokine Levels in Pregnant Women with Gestational Diabetes Between Weeks	VASPIN, VISFATIN, OMENTIN levels will be measured in patients with gestational diabetic,	Between 24-28 weeks of pregnancy, (an average of 6 months)