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

Study Overview

• Status: Terminated
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Interventional arm-Mediterranean diet; Other: Control Arm- regular nutritional instructions in accordance with the accepted nutritional guidelines

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petah-Tikva, Israel, 49202
    • Schneider Children's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rabin Medical Center
• Investigators: Principal Investigator: Liat de Vries, Dr, Schneider Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: May 4, 2014
• First Submitted That Met QC Criteria: May 4, 2014
• First Posted (Estimate): May 6, 2014

Study Record Updates

• Last Update Posted (Actual): October 20, 2017
• Last Update Submitted That Met QC Criteria: October 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Type 1 Diabetes; Lipid profile; Newly diagnosed; Mediterranean diet
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: rmc7800ctil