Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05505721 |
| Other study ID # |
food diary T1D |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 16, 2021 |
| Est. completion date |
October 31, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Ege University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
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
