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

NCT ID: NCT02131896

Last Updated: 2017-10-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-01
• Study Completion Date: 2016-06-30

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

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; Newly diagnosed; Lipid profile; Mediterranean diet

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Mediterranean Diet

Mediterranean Diet

Group Type: EXPERIMENTAL

Interventional arm-Mediterranean diet

Intervention Type: OTHER

Regular nutritional instructions

Regular nutritional instructions

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

Interventions

Interventional arm-Mediterranean diet

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liat de Vries, Dr

Role: PRINCIPAL_INVESTIGATOR

Schneider Children's Medical Center

Locations

Schneider Children's Medical Center

Petah Tikva, , Israel

Countries

Israel

Other Identifiers

rmc7800ctil

Identifier Type: -

Identifier Source: org_study_id