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

NCT05505721 | Completed

• 1 other identifier: food diary T1D
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Type 1 Diabetes; Children; Adolescent

Keywords

type 1 diabetes; children; adolescents; diet

Outcome Measures

Primary Outcomes (5)

• Macronutrient distribution

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

  day 1

• HbA1c

  As metabolic control parameter

  day 1

• Height (m),

  As a growth monitoring parameter

  day 1

• Weight (kg)

  As a growth monitoring parameter

  Day 1

• Body mass index (kg/m2)

  As a growth monitoring parameter

  Day 1

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Diabetes treatment, cases followed in Ege University Pediatrics Department, Pediatric Endocrine and Diabetes Department

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Ege University: lead

Study Sites (2)

Ege University

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

Ege University Faculty of Medicine Department of Pediatrics

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• yelda mansuroglu, MSc

  Ege University

  STUDY CHAIR

• gunay demir, MSc

  Ege University

  STUDY CHAIR

• samim ozen, Assoc Prof

  Ege University

  STUDY CHAIR

• sukran darcan, Prof Dr

  Ege University

  STUDY CHAIR

• damla goksen, Prof Dr

  Ege University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: August 18, 2022
• Study Start: March 16, 2021
• Primary Completion: March 16, 2022
• Study Completion: October 31, 2022
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

TU (2)