miRNA (microRNA) and FGF21 (Fibroblast Growth Factor-21) Profile in First Trimester and Gestational Diabetes Prediction

March 16, 2026 updated by: Kuntharee Traisrisilp, Chiang Mai University

miRNA and FGF21 Profile in First Trimester and Efficacy of Gestational Diabetes Prediction and Pregnancy Outcomes

The goal of this observational study is to compare miRNA and FGF21 in pregnancy with and without GDM (Gestational Diabetes) The main question it aims to answer that miRNA and FGF21 are different between two groups.

Participants will be retrieved blood sample during first trimester and undergone 100 gm OGTT (oral glucose challenge test) during 24-28 weeks of gestation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Pregnant women who attended antenatal care at Maharaj Nakorn Chiang Mai hospital during first trimester were recruited.

Participants received routine standard prenatal care except,

  1. additional blood test during 11-13 week 6 days (Blood was collected for further analysis)
  2. performed 75gm OGTT during 24-28 week

Baseline data and pregnancy outcome were reviewed.

Study Type

Observational

Enrollment (Actual)

160

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

  • Thailand
    • ChiangMai
      • Chiang Mai, ChiangMai, Thailand, 50200
        • Maharaj Nakorn ChiangMai Hospital

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

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy pregnant women with single alive fetus Participants will be subgroup based on the result of 100gm OGTT

Description

Inclusion Criteria:

  • singleton pregnant women who attend at our clinic in first trimester

Exclusion Criteria:

  • known underlying disease such as chronic hypertension, pregestational diabetes, SLE
  • normal structural fetal anatomical screening
  • incomplete obstetric data

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: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pregnancy with GDM
Pregnant women who positive test for 100gm OGTT (abnormal 2 or more blood glucose level according NDDG (National Diabetes Data Group) criteria)
Other: blood draw
Blood test for miRNA and FGF21. However, the laboratory result is not reported and not involved in management
Pregnancy without GDM
Pregnant women who negative test for 100gm OGTT
Other: blood draw
Blood test for miRNA and FGF21. However, the laboratory result is not reported and not involved in management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
miRNA profile
Time Frame: within 1 month after blood drawn
miRNA profile in first trimester of pregnancy and efficacy for GDM prediction
within 1 month after blood drawn

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FGF21 profile
Time Frame: 6 months after blood drawn
FGF21 profile in first trimester of pregnancy and efficacy for GDM prediction
6 months after blood drawn

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiang Mai University

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)

August 26, 2000

Primary Completion (Actual)

November 21, 2022

Study Completion (Estimated)

March 17, 2026

Study Registration Dates

First Submitted

November 20, 2022

First Submitted That Met QC Criteria

November 29, 2022

First Posted (Actual)

November 30, 2022

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OBG-2563-07494

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

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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