Afamin in Gestational Diabetes Mellitus

Afamin Levels in First Trimester Pregnancies With Gestational Diabetes Mellitus

This study includes pregnancies in 11 to 14 th gestational weeks. Investigators will sample maternal plasma in the first trimester and analyze maternal plasma afamin values. All these women will then be screened by two step OGTT. Investigators will compare afamin levels in GDM and control groups.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Diagnostic test: Afamin

Detailed Description

Background Gestational diabetes mellitus (GDM) is an endocrinopathy that occurs during pregnancy, and presents several clinical findings together with increased blood glucose levels. The frequency of GDM differs, while the incidence of the disease in Turkey is reported to be 7%. Most of the societies recommend screening all women with or without any risk factors in terms of GDM. The definitive diagnosis is made via oral glucose challenge test (OGTT). Early diagnosis and treatment are the key points to improve maternal and fetal outcomes. Different biomarkers are studied regarding GDM diagnosis starting from first trimester. However, there is not a worldwide accepted biomarker for defining the high risk group to the date. Afamin is known as an important indicator of oxidative stress. Moreover, oxidative stress itself is strongly associated with insulin resistance and obesity which are responsible from GDM pathogenesis.

Objective To investigate the association between first trimester maternal plasma afamin levels and GDM. Also, investigators aimed to understand the role of afamin for the prediction of GDM in this study.

Methods This is an observational prospective cohort study conducted in Department of Perinatology, Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital, University of Health Sciences, Ankara, Turkey. During 11 and 14 weeks of gestational, maternal blood will be obtained from eligible pregnant women, and samples will be stored at -80 oC. Informed written consent will be obtained from participants. Between 24th and 28th gestational weeks, all these women will be screened by two step OGTT. Then, afamin levels will be compared in GDM and control groups. Exclusion criteria are; multiple pregnancy, fetal anomalies, pregestational diabetes, underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders), age <18 or > 35 years, fasting glucose level > 105 mg/dL or random glucose level > 200 mg/dL.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 31 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women within 11 and 14 weeks of gestational weeks

Description

Inclusion criteria:

• singleton pregnancy,
• having no fetal anomalies
• having no pregestational diabetes
• having no underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders)
• age >18 or < 35 years
• fasting glucose level < 105 mg/dL

Exclusion Criteria:

• multiple pregnancy
• fetal anomalies
• pregestational diabetes
• underlying chronic diseases (hypertension, thyroid dysfunction, other endocrinopathies, autoimmune disorders)
• age <18 or > 35 years
• fasting glucose level > 105 mg/dL or random glucose level > 200 mg/dL

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gestational diabetes mellitus; First trimester pregnancies with gestational diabetes mellitus	Diagnostic test: Afamin; Plasma maternal afamin levels
Control; First trimester healthy pregnancies	Diagnostic test: Afamin; Plasma maternal afamin levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal plasma afamin levels In first trimester GDM prediction	The predictive value of first trimester maternal plasma afamin levels for the diagnosis of gestational diabetes mellitus in comparison with two step OGTT	6 months

Collaborators and Investigators

• Sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
• Collaborators: Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: August 9, 2019
• First Submitted That Met QC Criteria: August 10, 2019
• First Posted (Actual): August 13, 2019

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: December 14, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: Afamin in GDM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No