- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05505721
Do Children and Adolescents With Type 1 Diabetes Have Healthy Eating?:Real-life Data
February 25, 2023 updated by: Yasemin Atik Altinok, Ege University
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
Study Overview
Status
Completed
Conditions
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
Study Type
Observational
Enrollment (Actual)
130
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
İzmir, Turkey, 35100
- Ege University Faculty of Medicine Department of Pediatrics
-
-
Bornova
-
Izmir, Bornova, Turkey, 35100
- Ege University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Diabetes treatment, cases followed in Ege University Pediatrics Department, Pediatric Endocrine and Diabetes Department
Description
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.)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Macronutrient distribution
Time Frame: day 1
|
The macronutrient distribution of participant's diets will be evaluated for compliance with national and international guidelines.
|
day 1
|
|
HbA1c
Time Frame: day 1
|
As metabolic control parameter
|
day 1
|
|
Height (m),
Time Frame: day 1
|
As a growth monitoring parameter
|
day 1
|
|
Weight (kg)
Time Frame: Day 1
|
As a growth monitoring parameter
|
Day 1
|
|
Body mass index (kg/m2)
Time Frame: Day 1
|
As a growth monitoring parameter
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: 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 Director: Damla Goksen, Prof Dr, Ege University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 16, 2021
Primary Completion (Actual)
March 16, 2022
Study Completion (Actual)
October 31, 2022
Study Registration Dates
First Submitted
June 17, 2022
First Submitted That Met QC Criteria
August 16, 2022
First Posted (Actual)
August 18, 2022
Study Record Updates
Last Update Posted (Estimate)
February 28, 2023
Last Update Submitted That Met QC Criteria
February 25, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- food diary T1D
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.