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

NCT05632055 | Active Not Recruiting

• 1 other identifier: OBG-2563-07494
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• miRNA profile

  miRNA profile in first trimester of pregnancy and efficacy for GDM prediction

  within 1 month after blood drawn

Secondary Outcomes (1)

• FGF21 profile

  6 months after blood drawn

Study Arms (2)

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

Pregnancy without GDM

Pregnant women who negative test for 100gm OGTT

Other: blood draw

Interventions

blood draw OTHER

Blood test for miRNA and FGF21. However, the laboratory result is not reported and not involved in management

Pregnancy with GDM; Pregnancy without GDM

Eligibility Criteria

• Age: Up to 45 Years
• Gender Eligibility Details: because we study in pregnancy woman
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chiang Mai University: lead

Study Sites (1)

Maharaj Nakorn ChiangMai Hospital

Chiang Mai, ChiangMai, 50200, Thailand

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: November 30, 2022
• Study Start: August 26, 2000
• Primary Completion: November 21, 2022
• Study Completion: March 17, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

TH (1)