NCT05463237

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 levels of new adipocytokines such as Visfatin, Vaspin and Omentin secreted from visceral adipose tissue in patients diagnosed with GDM will be measured.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 18, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 31, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2023

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

June 30, 2022

Last Update Submit

August 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

Study Arms (2)

Pregnant women with gestational diabetes(n:87)

Visceral adipokine level will be examined in pregnant women with gestational diabetes.

Diagnostic Test: oral glucose tolerance testDiagnostic Test: Blood sample

Control group pregnant (n:87)

Visceral adipokine level will be examined in pregnant women with normal pregnant .

Diagnostic Test: oral glucose tolerance testDiagnostic Test: Blood sample

Interventions

oral glucose tolerance test (OGTT) used for the diagnosis of gestational diabetes mellitus between 24-28 weeks of gestation

Control group pregnant (n:87)Pregnant women with gestational diabetes(n:87)
Blood sampleDIAGNOSTIC_TEST

Measurement of blood Visfatin, Vaspin and Omentin levels in pregnant women with diabetes

Control group pregnant (n:87)Pregnant women with gestational diabetes(n:87)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Pregnant women over the age of 18 who are in the first trimester of pregnancy and are not diagnosed with diabetes

You may qualify if:

  • \>18 years of age
  • At the 2.st trimester of pregnancy

You may not qualify if:

  • History of with diabetes mellitus
  • Morbidly obese pregnants
  • History of abdomen liposuction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siirt Üniversity Medical Faculty

Siirt, 56000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes, GestationalObesityObesity, Abdominal

Interventions

Glucose Tolerance TestBlood Specimen Collection

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical AnalysisClinical Chemistry TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, EndocrineInvestigative TechniquesSpecimen HandlingPuncturesSurgical Procedures, Operative

Study Officials

  • Şerif Aksin, Assoc.Prof

    Siirt University Medical Faculty Obstetrics and Gynecology Departmant

    STUDY DIRECTOR
  • Şerif Aksin

    Siirt Üniversity Medical Faculty Obstetrics and Gynecology Department

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

June 30, 2022

First Posted

July 18, 2022

Study Start

October 31, 2022

Primary Completion

August 25, 2023

Study Completion

August 25, 2023

Last Updated

August 28, 2023

Record last verified: 2023-08

Locations