NCT07069296

Brief Summary

In this study, we aimed to investigate the relationship between obesity, glucose intolerance (insulin resistance), dyslipidemia and diabetes in children aged 5-12 born to mothers with Gestational Diabetes Mellitus (GDM) in Gaziosmanpaşa University Hospitals in Tokat province. The effect of GDM on both obesity and obesity-related disorders was examined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

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

Study Start

First participant enrolled

May 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 16, 2025

Completed
Last Updated

July 16, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

July 7, 2025

Last Update Submit

July 7, 2025

Conditions

Gestatiaonl Diabetes MellitusInsulin ResistanceDyslipaemiaObesity &Amp; Overweight

Keywords

Obesitychildrengestational diabetes mellitusinsulin resistancedyslipidemia

Outcome Measures

Primary Outcomes (1)

  • Obesity frequency

    This study aimed to evaluate the incidence of obesity in children aged 5-12 years born to mothers with GDM and to examine the role of GDM in the development of obesity

    1 to 2 year

Secondary Outcomes (1)

  • obesity-related metabolic disorders

    1 to 2 year

Study Arms (2)

children aged 5 to 12 years, born to mothers without a diagnosis of GDM

PLACEBO COMPARATOR

Control

Diagnostic Test: blood samples were collected from participantsDiagnostic Test: blood samples

children aged 5 to 12 years, born to mothers with a diagnosis of GDM

ACTIVE COMPARATOR

Patient group

Diagnostic Test: blood samples were collected from participantsDiagnostic Test: blood samples

Interventions

blood samples were collected from participantsDIAGNOSTIC_TEST

Blood samples obtained

children aged 5 to 12 years, born to mothers with a diagnosis of GDMchildren aged 5 to 12 years, born to mothers without a diagnosis of GDM
blood samplesDIAGNOSTIC_TEST

Blood sampling

children aged 5 to 12 years, born to mothers with a diagnosis of GDMchildren aged 5 to 12 years, born to mothers without a diagnosis of GDM

Eligibility Criteria

Age5 Years - 12 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 5-12 years, born to mothers diagnosed with GDM, were included in the study The control group consisted of children aged 5-12 years, recruited from a pediatric outpatient clinic, who had no history of maternal GDM

You may not qualify if:

  • Chi,ldren had chronic illnesses, or endocrinological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinic of Pediatrics

Tokat Province, Merkez, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Insulin ResistanceObesityOverweightDiabetes, GestationalDyslipidemias

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusEndocrine System DiseasesLipid Metabolism Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Ali Gul, Professor

    Tokat Gaziosmanpasa University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: A case-control study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof Dr Ali Gul

Study Record Dates

First Submitted

July 7, 2025

First Posted

July 16, 2025

Study Start

May 1, 2022

Primary Completion

May 1, 2023

Study Completion

July 1, 2023

Last Updated

July 16, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Concept - AG, EA; Design - AG, EA; Supervision - AG, TK, ST; Funding - AG, EK; Materials - EA, AG; Data Collection and/or Processing - EA, AG, EK; Analysis and/or Interpretation: AG, EA, TK, Writing - AG, EA; Critical Review - TK, ST.

Time Frame
May 15 2022

Locations

TU(1)