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CompletedNCT07069296Updated Jul 16, 2025

Impact of Gestational Diabetes on Childhood Obesity

An interventional study of blood samples were collected from participants and blood samples in Gestatiaonl Diabetes Mellitus, Insulin Resistance and Dyslipaemia, sponsored by Tokat Gaziosmanpasa University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 5 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-16.

Sponsored by Tokat Gaziosmanpasa University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 3 years 2 months after the study started (first participant enrolled May 2022, registered Jul 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Non-randomized
Ages
5 Years to 12 Years
Sex
All
01

Study 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.

Read the detailed description

Patients diagnosed with gestational diabetes mellitus (GDM) were identified through the automation system of Gaziosmanpaşa University Faculty of Medicine. Patient records were reviewed retrospectively, and the patients were contacted by phone to provide detailed information about the study. Children eligible for inclusion were invited to the hospital, and informed consent was obtained from their parents.

Patients presenting to the outpatient clinic were evaluated for obesity. Data including sex, gestational age at birth, birth weight, breastfeeding status, height, and body weight were recorded. Height and weight percentiles, body mass index (BMI), and Z-scores were calculated using the automated program available on the website of the Turkish Pediatric Endocrinology Society (https://www.ceddcozum.com/).

During height measurements, children were instructed to remove their shoes and stand upright against a flat wall so that the back of their head, shoulders, hips, and heels touched the wall. A stadiometer was used to perform the measurement. Body weight was measured using a precise digital scale while the children wore light clothing and no shoes. Based on their percentiles, children were categorized as underweight, normal weight, overweight, or obese. A BMI at or above the 95th percentile was classified as "obese," between the 85th and 94th percentile as "overweight," between the 5th and 84th percentile as "normal weight," and below the 5th percentile as "underweight" (40, 41). The study group included those with a BMI between the 5th and 85th percentile (BMI-SDS between -1 and +1), while the obese group consisted of those at or above the 95th percentile (BMI-SDS +2 and above) (42).

Fasting blood samples were drawn after an 8-hour fasting period. From all children, laboratory tests including total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), very low-density lipoprotein (VLDL), high-density lipoprotein (HDL), fasting insulin, glucose, electrolytes (Na, K, Cl), blood urea nitrogen (BUN), creatinine, complete blood count, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) levels were analyzed. After obtaining the results, the homeostatic model assessment of insulin resistance (HOMA-IR) was calculated using the following formula:

HOMA-IR = [fasting insulin (mIU/ml) × fasting glucose (mg/dl)] / 405. Insulin resistance in children was determined based on HOMA-IR values. In prepubertal children, values above 2.67 for boys and 2.22 for girls were considered positive. In pubertal children, values above 5.22 for boys and 3.82 for girls were considered positive (43).

For the control group, healthy children aged 5-12 years without any chronic illness or endocrinological disorder, who presented to the pediatric outpatient clinic at Gaziosmanpaşa University Faculty of Medicine Hospital, were included. Informed consent was obtained from their parents. Sex, gestational age, birth weight, breastfeeding status, height, weight, and BMI were recorded, and blood tests were performed.

An application for funding support was submitted to the Scientific Research Projects Coordination Unit of Gaziosmanpaşa University. The project was approved for funding on 31.05.2022.

Ethical approval was obtained from the Tokat Gaziosmanpaşa University Clinical Research Ethics Committee (Approval Number: 22-KAEK-10). Additionally, permission was obtained from the hospital administration to access and use the hospital automation system.

Patients with congenital heart disease were excluded from the study. A total of 35 children born to mothers with gestational diabetes were identified. One child was excluded due to congenital heart disease, and the study was conducted with 34 children. A total of 40 healthy children were included in the control group. Children with chronic diseases such as hypothyroidism, familial hyperlipidemia, or diabetes were excluded from the control group.

Descriptive statistics were used to summarize the general characteristics of the study groups. Continuous variables were expressed as mean ± standard deviation (SD), and categorical variables as n (%). The significance of differences between group means for continuous variables was assessed using the Independent Samples t-test. Relationships between categorical variables were examined using cross-tabulations and Chi-square tests. Pearson correlation coefficients were used to assess relationships between continuous variables. A p-value of \<0.05 was considered statistically significant. Statistical analyses were performed using SPSS version 19.0 (Chicago, IL, USA)

02

Conditions studied

  • Gestatiaonl Diabetes Mellitus
  • Insulin Resistance
  • Dyslipaemia
  • Obesity &Amp; Overweight

Keywords

  • Obesity
  • children
  • gestational diabetes mellitus
  • insulin resistance
  • dyslipidemia
03

In context

Insulin Resistance

1,959 studies on the registry are indexed under Insulin Resistance; 305 are open to participants now.

This study's enrollment of 74 is above the median of 40 across 1,535 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

Tokat Gaziosmanpasa University is the lead sponsor of 164 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Chi,ldren had chronic illnesses, or endocrinological disorders
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
74 participants (actual)

Study arms

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

    Control

    Diagnostic Test: blood samples were collected from participants · Diagnostic Test: blood samples

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

    Patient group

    Diagnostic Test: blood samples were collected from participants · Diagnostic Test: blood samples

Interventions

  • Diagnostic testblood samples were collected from participants

    Blood samples obtained

  • Diagnostic testblood samples

    Blood sampling

06

What researchers measure

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

    Time frame: 1 to 2 year

Secondary outcomes

  1. obesity-related metabolic disorders

    Fasting blood samples were collected to analyze serum insulin levels, lipid profiles, thyroid function tests, fasting glucose. The homeostasis model assessment of insulin resistance (HOMA-IR) was calculated using the following formula: HOMA-IR = \[fasting insulin (mIU/mL) × fasting glucose (mg/dL)\]/405 (12, 13). Insulin resistance (IR) was defined as a HOMA-IR value greater than 2.67 in prepubertal boys, 2.22 in prepubertal girls, 5.22 in pubertal boys, and 3.82 in pubertal girls

    Time frame: 1 to 2 year

07

Study locations

1 site
  • Clinic of Pediatrics
    Tokat Province, Merkez, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: Yes — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07069296
Lead sponsor
Tokat Gaziosmanpasa University
Responsible party
Ali Gul (Prof Dr Ali Gul, Tokat Gaziosmanpasa University) — Principal investigator
First posted
Jul 16, 2025
Start date
May 1, 2022
Primary completion
May 1, 2023
Completion
Jul 1, 2023
Last update
Jul 16, 2025

Study contacts

Ali Gul, Professor
study chair · Tokat Gaziosmanpasa University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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