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

• Sponsor: Siirt University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05463237
• Collaborator: (none)
• Enrollment: 87
• Anticipated Duration (Months): 4

Study Details

Study Description

Brief 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 investigators plan to determine the relationship between visceral adipose tissue thickness and the development of GDM by measuring the adipose tissue thickness in the 1st trimester and then measuring the levels of new adipocytokines such as Visfatin, Vaspin and Omentin secreted from the visceral adipose tissue in patients diagnosed with GDM among these patients. Thus, proving the existence of this relationship will enable to take early precautions in terms of GDM by detecting the pregnant women at risk in the 1st trimester.

Condition or Disease	Intervention/Treatment	Phase
Gestational Diabetes; Obesity; Visceral Obesity	Other: ultrasonographic examination; Diagnostic Test: oral glucose tolerance test; Diagnostic Test: Blood sample

Detailed Description

The investigators aim in this study was to measure the thickness of adipose tissue in the 1st trimester and to look at 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, ultrasonographic visceral fat thickness measurement will be routinely performed on all pregnant women who come to their normal routine controls at 11-14 weeks in Siirt Training and Research Hospital between June 2022 and June 2023, 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 1st trimester, visceral adipose tissue thickness will be measured with the help of ultrasound. 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. In the light of the information thus obtained, the investigators plan to determine whether there is a relationship between adipose tissue thickness measured in the 1st trimester, Visfatin, Vaspin and Omentin levels measured in the second trimester, and GDM.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 87 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: The Relation Between Visceral Adipocykines Gestational Diabetes Mellitus
• Anticipated Study Start Date: Aug 15, 2022
• Anticipated Primary Completion Date: Dec 15, 2022
• Anticipated Study Completion Date: Dec 15, 2022

Outcome Measures

Primary Outcome Measures

1. 24-28. Visceral Adipokine Levels in Pregnant Women with Gestational Diabetes Between Weeks [Between 24-28 weeks of pregnancy, (an avarage of 6 months)]

   VASPIN, VISFATIN, OMENTIN levels will be measured in patients with gestational diabetic,

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 18 years of age

• At the 1.st trimester of pregnancy

Exclusion Criteria:

• History of with diabestes mellitus

• Morbidly obese pregnants

• History of abdomen liposuction

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Siirt University

Investigators

• Study Director: Şerif Aksin, Assoc.Prof, Siirt University Medical Faculty Obstetrics and Gynecology Departmant

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Serif Aksin, associate professor, Siirt University
• ClinicalTrials.gov Identifier: NCT05463237
• Other Study ID Numbers: SiirtUNI
• First Posted: Jul 18, 2022
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Obesity; Obesity, Abdominal

Study Results

No Results Posted as of Aug 3, 2022