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

NCT ID: NCT05505721

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-16

Study Completion Date

2022-10-31

Brief Summary

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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

Detailed Description

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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

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Type 1 Diabetes Children Adolescent

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.)
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University

OTHER

Sponsor Role lead

Responsible Party

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Yasemin Atik Altinok

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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yelda mansuroglu, MSc

Role: STUDY_CHAIR

Ege University

gunay demir, MSc

Role: STUDY_CHAIR

Ege University

samim ozen, Assoc Prof

Role: STUDY_CHAIR

Ege University

sukran darcan, Prof Dr

Role: STUDY_CHAIR

Ege University

damla goksen, Prof Dr

Role: STUDY_DIRECTOR

Ege University

Locations

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Ege University

Izmir, Bornova, Turkey (Türkiye)

Site Status

Ege University Faculty of Medicine Department of Pediatrics

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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food diary T1D

Identifier Type: -

Identifier Source: org_study_id

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