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NCT Number: NCT05505721

Do Children and Adolescents With Type 1 Diabetes Have Healthy Eating?:Real-life Data

The aim of the study is to examine the relationship between the nutritional content of the diet consumed by children and adolescents (0-18 years old) with the diagnosis of type 1 diabetes and metabolic control. In this cross-sectional study, 150 children and adolescents with type 1 diabetes who came to Ege University Child Health and Diseases Department, Pediatric Endocrine and Diabetes Department for regular check-ups (4 diabetes control/year) and kept food consumption records in the last 1 year will be included. Body weight and height measurements of the cases will be done by the same person in Ege University Pediatric Endocrinology and Diabetes BD Polyclinic. Turkish Standard Institute approved Baster brand weighing instrument with 0.1 kg intervals and height measurements will be made with Harpander brand stadiometer with 0.1 cm intervals. SD scores of body weight, height and body mass index for age Neyzi et al. It will be calculated using the reference values developed for Turkish children by Age, diabetes age, gender, height - body weight-body mass index SD score, HbA1c level, daily energy intake, percentage of energy from carbohydrate-protein-fat-saturated fat in energy, daily fiber intake amount of the cases will be recorded in the case report form. The biochemical values of the participants will be taken from the file records. The data will be entered into the statistical package program and the patients' 1) carbohydrate, protein, fat, saturated fat intake, 2) vitamin-mineral intake, and 3) fruit and vegetable consumption will be compared with the recommendations in national and international guidelines and their relationship with metabolic control will be investigated

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ege University, Izmir, Bornova, Turkey (Türkiye)

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About this study

In this cross-sectional study, 150 children and adolescents with type 1 diabetes who came to Ege University Child Health and Diseases Department, Pediatric Endocrine and Diabetes Department for regular check-ups (4 diabetes control/year) and kept food consumption records in the last 1 year will be included. Body weight and height measurements of the cases will be done by the same person in Ege University Pediatric Endocrinology and Diabetes BD Polyclinic. Turkish Standard Institute approved Baster brand weighing instrument with 0.1 kg intervals and height measurements will be made with Harpander brand stadiometer with 0.1 cm intervals. SD scores of body weight, height and body mass index for age Neyzi et al. It will be calculated using the reference values developed for Turkish children by Age, diabetes age, gender, height - body weight-body mass index SD score, HbA1c level, daily energy intake, percentage of energy from carbohydrate-protein-fat-saturated fat in energy, daily fiber intake amount of the cases will be recorded in the case report form. The biochemical values of the participants will be taken from the file records. The data will be entered into the statistical package program and the patients' 1) carbohydrate, protein, fat, saturated fat intake, 2) vitamin-mineral intake, and 3) fruit and vegetable consumption will be compared with the recommendations in national and international guidelines and their relationship with metabolic control will be investigated

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • who came to regular check-ups in the last 1 year (4 diabetes checks/year)
  • children and adolescents who keep a food diary for 3 days before coming to diabetes control by their own/caregiver

Exclusion criteria

  • Cases that do not accept to fill in the 'Informed Consent Form'
  • Cases with diseases accompanying T1DM (autoimmune diseases such as celiac, cystic fibrosis, etc.)

Treatment and study plan

Primary outcomes

  1. Macronutrient distribution

    Time frame: day 1

    The macronutrient distribution of participant's diets will be evaluated for compliance with national and international guidelines.

  2. HbA1c

    Time frame: day 1

    As metabolic control parameter

  3. Height (m),

    Time frame: day 1

    As a growth monitoring parameter

  4. Weight (kg)

    Time frame: Day 1

    As a growth monitoring parameter

  5. Body mass index (kg/m2)

    Time frame: Day 1

    As a growth monitoring parameter

Sponsors and collaborators

Lead sponsor

Ege University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 18, 2022
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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