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Gestatiaonl Diabetes MellitusNCT07069296

Impact of Gestational Diabetes on Childhood Obesity

A study testing blood samples were collected from participants and blood samples in people with Gestatiaonl Diabetes Mellitus and Insulin Resistance, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 12 yearsHealthy volunteers can take part
What is being tested?
blood samples were collected from participants and blood samples
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
74 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 May 2022to 1 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 12 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • Chi,ldren had chronic illnesses, or endocrinological disorders

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Clinic of Pediatrics

    Tokat Province, Merkez

Other trials in Turkey (Türkiye)

About this study

Official title: Impact of Gestational Diabetes on Childhood Obesity and Related Metabolic Disorders in Children Aged 5-12

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)

Being tested
blood samples were collected from participants, blood samples
Keywords
Obesity, children, gestational diabetes mellitus, insulin resistance, dyslipidemia
Medical subject headings
Insulin Resistance, Obesity, Overweight, Diabetes, Gestational, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood samples were collected from participantsDiagnostic test

    Blood samples obtained

  • blood samplesDiagnostic test

    Blood sampling

Study groups in NCT07069296
Study groupRoleWhat they receive
children aged 5 to 12 years, born to mothers without a diagnosis of GDMPlacebo comparatorControl
Receives: Diagnostic Test: blood samples were collected from participants; Diagnostic Test: blood samples
children aged 5 to 12 years, born to mothers with a diagnosis of GDMActive comparatorPatient group
Receives: Diagnostic Test: blood samples were collected from participants; Diagnostic Test: blood samples

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 1 to 2 year

Secondary outcomes (1)
  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

    Measured: 1 to 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2025
  2. Study start1 May 2022
  3. Primary completion1 May 2023
  4. Study completion1 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
A case-control study
Masking
None (open label)
Enrolment
74 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07069296
Sponsor's protocol ID
2022/59
Status last verified
Jul 2025
First submitted
7 Jul 2025
Last updated
16 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing blood samples were collected from participants and blood samples in people with Gestatiaonl Diabetes Mellitus and Insulin Resistance, run by Tokat Gaziosmanpasa University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Obesity frequency (time frame: 1 to 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.

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