History of Changes for Study: NCT05505721

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

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	August 16, 2022	None (earliest Version on record)
2	December 2, 2022	Study Status
3	February 25, 2023	Recruitment Status and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	food diary T1D
Brief Title:	Do Children and Adolescents With Type 1 Diabetes Have Healthy Eating?:Real-life Data
Official Title:	Do Children and Adolescents With Type 1 Diabetes Have Healthy Eating?:Real-life Data
Secondary IDs:

Study Status


Record Verification:	February 2023
Overall Status:	Completed
Study Start:	March 16, 2021
Primary Completion:	March 16, 2022 [Actual]
Study Completion:	October 31, 2022 [Actual]

First Submitted:	June 17, 2022
First Submitted that Met QC Criteria:	August 16, 2022
First Posted:	August 18, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	February 25, 2023
Last Update Posted:	February 28, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Ege University
Responsible Party:	Principal Investigator Investigator: Yasemin Atik Altinok Official Title: principal investigator Affiliation: Ege University
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	No

Study Description

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

Detailed Description:

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


Conditions:	Type 1 Diabetes Children Adolescent
Keywords:	type 1 diabetes children adolescents diet

Study Design


Study Type:	Observational
Observational Study Model:	Case-Only
Time Perspective:	Prospective
Biospecimen Retention:
Biospecimen Description:
Enrollment:	130 [Actual]
Number of Groups/Cohorts	0

Groups and Interventions

Outcome Measures


Primary Outcome Measures:
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

Eligibility


Study Population:	Diabetes treatment, cases followed in Ege University Pediatrics Department, Pediatric Endocrine and Diabetes Department
Sampling Method:	Non-Probability Sample
Minimum Age:	1 Month
Maximum Age:	18 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	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.)

Contacts/Locations


Study Officials:	yelda mansuroglu, MSc Study Chair Ege University
	gunay demir, MSc Study Chair Ege University
	samim ozen, Assoc Prof Study Chair Ege University
	sukran darcan, Prof Dr Study Chair Ege University
	damla goksen, Prof Dr Study Director Ege University
Locations:	Turkey
	Ege University Faculty of Medicine Department of Pediatrics İzmir, Turkey, 35100
	Turkey, Bornova
	Ege University Izmir, Bornova, Turkey, 35100

IPDSharing


Plan to Share IPD:	Undecided

References


Citations:
Links:
Available IPD/Information: