Nutritional therapy has a major role in diabetes care, achieving and maintaining metabolic control: normal glucose homeostasis, normal lipid profile, normal blood pressure and desirable weight. Controlled nutritional diet, as introduced by the professional committees aims at achieving better general health condition. There is a growing body of evidence showing that Mediterranean diet has a major role in prevention of diabetes sequelae in type 2 diabetes patients. Hitherto, the effects of Mediterranean diet on patients with type 1 diabetes has not been studied, with the exception of one Italian study. Six months after education to consume Mediterranean diet in a cohort of 96 children with type 1 diabetes the authors observed decreased fat and cholesterol consumption, increased dietary fiber consumption, lower LDL cholesterol levels and better HDL to LDL cholesterol ratio. The proposed study is aimed to assess the impact of Mediterranean nutrition compared to the accepted nutritional guidelines, in newly diagnosed type 1 children and adolescents on lipid profile, metabolic control, C peptide, daily insulin dose, Inflammatory parameters, endothelial function and anthropometric parameters 12 months following diagnosis. The study designed as a two parallel arms, randomized, single center, intervention study. Patients enrolled to the study will be randomly assigned, to one of the following groups in a 1:1 ratio. Interventional Arm: Patients assigned to the interventional arm will receive nutritional instructions of Mediterranean diet and Control Group: Patients assigned to the interventional arm will receive regular nutritional instructions in accordance with the accepted nutritional guidelines
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
4
Schneider Children's Medical Center
Petah Tikva, Israel
lipid profile
fasting blood lipid profile
Time frame: At the end of the study-after 12 months
Metabolic control
Metabolic control expressed as HbA1c level
Time frame: At the end of the study-after 12 months
mean and SD of blood glucose
Metabolic control expressed as mean and SD of downloaded blood glucose values from patient's personal glucometer
Time frame: At the end of the study-after 12 months
Peak stimulated C peptide
Peak stimulated C peptide \> o.2 pmol/mL
Time frame: At the end of the study- after 12 months
Daily insulin dose
Daily insulin dose adjusted for body weight
Time frame: At the end of the study- after 12 months
Percent of subjects who require a daily insulin dose < o,5 IU/kg
Time frame: At the end of the study- after 12 months
Frequency and severity of hypoglycemic episodes
Time frame: At the end of the study- after 12 months
Anthropometric parameters
Anthropometric parameters: Body weight ,BMI SDS, body composition and weight change from diagnosis to 12 months after diagnosis
Time frame: At the end of the study- after 12 months
weight change from at least 1 year before diagnosis to 12 months after diagnosis
Time frame: At the end of the study-after 12 months
Inflammatory parameters
Inflammatory parameters: TNF, CRP, IL-6, fibrinogen
Time frame: At the end of the study-after 12 months
Endothelial function
Endothelial function: Doppler assessment of the tunica intima
Time frame: At the end of the study-after 12 months
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