Clinical trial NCT05505721: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes
Children
Adolescent
Keywords: type 1 diabetes
children
adolescents
diet
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2022-08-18
Enrollment: 130
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diabetes treatment, cases followed in Ege University Pediatrics Department, Pediatric Endocrine and Diabetes Department

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

Eligibility 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.)

Primary outcomes:
measure: Macronutrient distribution
timeFrame: day 1
measure: HbA1c
timeFrame: day 1
measure: Height (m),
timeFrame: day 1
measure: Weight (kg)
timeFrame: Day 1
measure: Body mass index (kg/m2)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
state: Bornova
city: İzmir
country: Turkey
facility: Ege University Faculty of Medicine Department of Pediatrics
Study officials:
affiliation: Ege University
name: yelda mansuroglu, MSc
role: STUDY_CHAIR
affiliation: Ege University
name: gunay demir, MSc
role: STUDY_CHAIR
affiliation: Ege University
name: samim ozen, Assoc Prof
role: STUDY_CHAIR
affiliation: Ege University
name: sukran darcan, Prof Dr
role: STUDY_CHAIR
affiliation: Ege University
name: damla goksen, Prof Dr
role: STUDY_DIRECTOR
References: