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

Study Overview
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Brief Summary
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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

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: Interventional arm-Mediterranean diet
* Other: Control Arm- regular nutritional instructions in accordance with the accepted nutritional guidelines


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents/guardian are willing and able to sign an informed consent form Age 5-18 years Diagnosis with type 1 diabetes for up to 2 months prior to screening Peak C peptide > o.2 pmol/mL Exclusion Criteria: The patient has any significant disease or conditions, including psychiatric disorders that in the opinion of the principal investigator might interfere with patient's compliance or ability to complete the study Any concomitant disease that might impact body composition, physical activity level and/or eating habits Active celiac disease, hashimoto thyroiditis or uncontrolled Graves' disease Down syndrome, Turner, inflammatory bowel disease Patients treated with antipsychotic drugs, steroids, or other drugs that might affect body weight and appetite. Patient who suffers from eating disorders Patients participating in other device or drug studies

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean Diet<br>Mediterranean Diet | Other: Interventional arm-Mediterranean diet<br> <br> |
| Active Comparator: Regular nutritional instructions<br>Regular nutritional instructions | Other: Control Arm- regular nutritional instructions in accordance with the accepted nutritional guidelines<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid profile | fasting blood lipid profile | At the end of the study-after 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic control | Metabolic control expressed as HbA1c level | 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 | At the end of the study-after 12 months | 
| Peak stimulated C peptide | Peak stimulated C peptide > o.2 pmol/mL | At the end of the study- after 12 months | 
| Daily insulin dose | Daily insulin dose adjusted for body weight | At the end of the study- after 12 months | 
| Percent of subjects who require a daily insulin dose < o,5 IU/kg |  | At the end of the study- after 12 months | 
| Frequency and severity of hypoglycemic episodes |  | 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 | At the end of the study- after 12 months | 
| weight change from at least 1 year before diagnosis to 12 months after diagnosis |  | At the end of the study-after 12 months | 
| Inflammatory parameters | Inflammatory parameters: TNF, CRP, IL-6, fibrinogen | At the end of the study-after 12 months | 
| Endothelial function | Endothelial function: Doppler assessment of the tunica intima | At the end of the study-after 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Newly diagnosed, Lipid profile, Mediterranean diet