Clinical trial NCT02131896: 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
Overall status: TERMINATED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Newly diagnosed
Lipid profile
Mediterranean diet
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 4
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


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

Primary outcomes:
measure: lipid profile
timeFrame: At the end of the study-after 12 months
Secondary outcomes:
measure: Metabolic control
timeFrame: At the end of the study-after 12 months
measure: mean and SD of blood glucose
timeFrame: At the end of the study-after 12 months
measure: Peak stimulated C peptide
timeFrame: At the end of the study- after 12 months
measure: Daily insulin dose
timeFrame: At the end of the study- after 12 months
measure: Percent of subjects who require a daily insulin dose < o,5 IU/kg
timeFrame: At the end of the study- after 12 months
measure: Frequency and severity of hypoglycemic episodes
timeFrame: At the end of the study- after 12 months
measure: Anthropometric parameters
timeFrame: At the end of the study- after 12 months
measure: weight change from at least 1 year before diagnosis to 12 months after diagnosis
timeFrame: At the end of the study-after 12 months
measure: Inflammatory parameters
timeFrame: At the end of the study-after 12 months
measure: Endothelial function
timeFrame: At the end of the study-after 12 months
Other outcomes:
Locations:
city: Petah-Tikva
country: Israel
facility: Schneider Children's Medical Center
Study officials:
affiliation: Schneider Children's Medical Center
name: Liat de Vries, Dr
role: PRINCIPAL_INVESTIGATOR
References: