miRNA (microRNA) and FGF21 (Fibroblast Growth Factor-21)... | NCT05632055

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

NCT05632055

Sponsor

Chiang Mai University

Status

Active, not recruiting

Last Update Posted

Mar 18, 2026Actual

Enrollment

160Actual

Phase

Not provided

Conditions

Gestational Diabetes

Interventions

blood draw

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 26, 2000Actual

Primary Completion Date

Nov 21, 2022Actual

Completion Date

Mar 17, 2026Estimated

First Submitted Date

Nov 20, 2022

First Submission Date that Met QC Criteria

Nov 29, 2022

First Posted Date

Nov 30, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2026

Last Update Posted Date

Mar 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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,

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

Baseline data and pregnancy outcome were reviewed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

160Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

because we study in pregnancy woman

Minimum Age

Not provided

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Maharaj Nakorn ChiangMai Hospital		Chiang Mai	ChiangMai	50200	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016640	Diabetes, Gestational

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided