Type 1 Diabetes Clinical Trial
Official title:
The Effects of Mediterranean Diet on Remission, Lipid Profile, Weight and Body Composition in Children and Adolescents With Newly Diagnosed Type 1 Diabetes
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
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