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Clinical Trials/NCT07069296
NCT07069296CompletedNot Applicable

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

Tokat Gaziosmanpasa University1 site in 1 country74 target enrollmentStarted: May 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
74
Locations
1
Primary Endpoint
Obesity frequency

Study Overview

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.

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).

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
5 Years to 12 Years (Child)
Sex
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

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

Arms & Interventions

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

Placebo Comparator

Control

Intervention: blood samples were collected from participants (Diagnostic Test)

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

Placebo Comparator

Control

Intervention: blood samples (Diagnostic Test)

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

Active Comparator

Patient group

Intervention: blood samples were collected from participants (Diagnostic Test)

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

Active Comparator

Patient group

Intervention: blood samples (Diagnostic Test)

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • obesity-related metabolic disorders(1 to 2 year)

Investigators

Sponsor
Tokat Gaziosmanpasa University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ali Gul

Prof Dr Ali Gul

Tokat Gaziosmanpasa University

Study Sites (1)

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