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

Sponsor

Rabin Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT02131896

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Other: Interventional arm-Mediterranean diet Other: Control Arm- regular nutritional instructions in accordance with the accepted nutritional guidelines	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Dec 1, 2014

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Mediterranean Diet

Mediterranean Diet

Other: Interventional arm-Mediterranean diet

Active Comparator: Regular nutritional instructions

Regular nutritional instructions

Other: Control Arm- regular nutritional instructions in accordance with the accepted nutritional guidelines

Outcome Measures

Primary Outcome Measures

lipid profile [At the end of the study-after 12 months]
fasting blood lipid profile

Secondary Outcome Measures

Metabolic control [At the end of the study-after 12 months]
Metabolic control expressed as HbA1c level
mean and SD of blood glucose [At the end of the study-after 12 months]
Metabolic control expressed as mean and SD of downloaded blood glucose values from patient's personal glucometer
Peak stimulated C peptide [At the end of the study- after 12 months]
Peak stimulated C peptide > o.2 pmol/mL
Daily insulin dose [At the end of the study- after 12 months]
Daily insulin dose adjusted for body weight
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 [At the end of the study- after 12 months]
Anthropometric parameters: Body weight ,BMI SDS, body composition and weight change from diagnosis to 12 months after diagnosis
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 [At the end of the study-after 12 months]
Inflammatory parameters: TNF, CRP, IL-6, fibrinogen
Endothelial function [At the end of the study-after 12 months]
Endothelial function: Doppler assessment of the tunica intima

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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