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).
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
- Conditions the study is for
- Gestatiaonl Diabetes Mellitus, Insulin Resistance, Dyslipaemia
- 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.
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 group | Role | What they receive |
|---|---|---|
| children aged 5 to 12 years, born to mothers without a diagnosis of GDM | Placebo comparator | Control 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 GDM | Active comparator | Patient 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.
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)
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.
- First posted16 Jul 2025
- Study start1 May 2022
- Primary completion1 May 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestatiaonl Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Gul, Tokat Gaziosmanpasa University
- Investigators
- Ali Gul, Professor, Study chair, Tokat Gaziosmanpasa University
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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gestational Diabetes on Childhood Obesity and Related Metabolic Disorders in Children Aged 5-12
- ClinicalTrials.gov ID
- NCT07069296
- Acronym / sponsor ID
- 2022/59
- Keywords
- Obesity, children, gestational diabetes mellitus, insulin resistance, dyslipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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)
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A case-control study
| Arm | Type | Receives |
|---|---|---|
| children aged 5 to 12 years, born to mothers without a diagnosis of GDM | Placebo comparator | Diagnostic Test: blood samples were collected from participants, Diagnostic Test: blood samplesControl |
| children aged 5 to 12 years, born to mothers with a diagnosis of GDM | Active comparator | Diagnostic Test: blood samples were collected from participants, Diagnostic Test: blood samplesPatient group |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Chi,ldren had chronic illnesses, or endocrinological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samples were collected from participantsBlood samples obtained | Diagnostic test | children aged 5 to 12 years, born to mothers with a diagnosis of GDM, children aged 5 to 12 years, born to mothers without a diagnosis of GDM |
| blood samplesBlood sampling | Diagnostic test | children aged 5 to 12 years, born to mothers with a diagnosis of GDM, children aged 5 to 12 years, born to mothers without a diagnosis of GDM |
Primary outcome
Obesity frequency
Time frame: 1 to 2 year
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 secondary outcome
obesity-related metabolic disorders
Time frame: 1 to 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Gul, Professor study chair
Tokat Gaziosmanpasa University
1 site in 1 country: see every site and its status.
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.