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

Primary Purpose

Type 1 Diabetes

Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Interventional arm-Mediterranean diet
Control Arm- regular nutritional instructions in accordance with the accepted nutritional guidelines
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, Newly diagnosed, Lipid profile, Mediterranean diet

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Schneider Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mediterranean Diet

Regular nutritional instructions

Arm Description

Mediterranean Diet

Regular nutritional instructions

Outcomes

Primary Outcome Measures

lipid profile
fasting blood lipid profile

Secondary Outcome Measures

Metabolic control
Metabolic control expressed as HbA1c level
mean and SD of blood glucose
Metabolic control expressed as mean and SD of downloaded blood glucose values from patient's personal glucometer
Peak stimulated C peptide
Peak stimulated C peptide > o.2 pmol/mL
Daily insulin dose
Daily insulin dose adjusted for body weight
Percent of subjects who require a daily insulin dose < o,5 IU/kg
Frequency and severity of hypoglycemic episodes
Anthropometric parameters
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
Inflammatory parameters
Inflammatory parameters: TNF, CRP, IL-6, fibrinogen
Endothelial function
Endothelial function: Doppler assessment of the tunica intima

Full Information

First Posted
May 4, 2014
Last Updated
October 19, 2017
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02131896
Brief Title
The Effects of Mediterranean Diet on Remission, Lipid Profile, Weight and Body Composition in Children and Adolescents With Newly Diagnosed Type 1 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Recruitment difficulties
Study Start Date
December 1, 2014 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 Diabetes, Newly diagnosed, Lipid profile, Mediterranean diet

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mediterranean Diet
Arm Type
Experimental
Arm Description
Mediterranean Diet
Arm Title
Regular nutritional instructions
Arm Type
Active Comparator
Arm Description
Regular nutritional instructions
Intervention Type
Other
Intervention Name(s)
Interventional arm-Mediterranean diet
Intervention Type
Other
Intervention Name(s)
Control Arm- regular nutritional instructions in accordance with the accepted nutritional guidelines
Primary Outcome Measure Information:
Title
lipid profile
Description
fasting blood lipid profile
Time Frame
At the end of the study-after 12 months
Secondary Outcome Measure Information:
Title
Metabolic control
Description
Metabolic control expressed as HbA1c level
Time Frame
At the end of the study-after 12 months
Title
mean and SD of blood glucose
Description
Metabolic control expressed as mean and SD of downloaded blood glucose values from patient's personal glucometer
Time Frame
At the end of the study-after 12 months
Title
Peak stimulated C peptide
Description
Peak stimulated C peptide > o.2 pmol/mL
Time Frame
At the end of the study- after 12 months
Title
Daily insulin dose
Description
Daily insulin dose adjusted for body weight
Time Frame
At the end of the study- after 12 months
Title
Percent of subjects who require a daily insulin dose < o,5 IU/kg
Time Frame
At the end of the study- after 12 months
Title
Frequency and severity of hypoglycemic episodes
Time Frame
At the end of the study- after 12 months
Title
Anthropometric parameters
Description
Anthropometric parameters: Body weight ,BMI SDS, body composition and weight change from diagnosis to 12 months after diagnosis
Time Frame
At the end of the study- after 12 months
Title
weight change from at least 1 year before diagnosis to 12 months after diagnosis
Time Frame
At the end of the study-after 12 months
Title
Inflammatory parameters
Description
Inflammatory parameters: TNF, CRP, IL-6, fibrinogen
Time Frame
At the end of the study-after 12 months
Title
Endothelial function
Description
Endothelial function: Doppler assessment of the tunica intima
Time Frame
At the end of the study-after 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liat de Vries, Dr
Organizational Affiliation
Schneider Children's Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Children's Medical Center
City
Petah-Tikva
ZIP/Postal Code
49202
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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