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

Type 1 Diabetes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02131896
• Other study ID #: rmc7800ctil
• Status: Terminated
• Phase: N/A
• First received: May 4, 2014
• Last updated: October 19, 2017
• Start date: December 1, 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2017
• Source: Rabin Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Interventional arm-Mediterranean diet

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

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center	Petah-Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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