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

NCT02131896 | Terminated

• 1 other identifier: rmc7800ctil
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• lipid profile

  fasting blood lipid profile

  At the end of the study-after 12 months

Secondary Outcomes (10)

• Metabolic control

  At the end of the study-after 12 months

• mean and SD of blood glucose

  At the end of the study-after 12 months

• Peak stimulated C peptide

  At the end of the study- after 12 months

• Daily insulin dose

  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

Study Arms (2)

Mediterranean Diet

EXPERIMENTAL

Mediterranean Diet

Other: Interventional arm-Mediterranean diet

Regular nutritional instructions

ACTIVE COMPARATOR

Regular nutritional instructions

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

Interventions

Interventional arm-Mediterranean diet OTHER

Mediterranean Diet

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

Regular nutritional instructions

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Children's Medical Center

Petah Tikva, 49202, Israel

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Liat de Vries, Dr

  Schneider Children's Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2014
• First Posted: May 6, 2014
• Study Start: December 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 20, 2017

Record last verified: 2017-01

Locations

IL (1)