The Effects of Mediterranean Diet on Remission, Lipid Profile, Weight and Body Composition in Children and Adolescents With Newly Diagnosed Type 1 Diabetes
- Conditions
- Type 1 Diabetes
- Interventions
- Other: Control Arm- regular nutritional instructions in accordance with the accepted nutritional guidelinesOther: Interventional arm-Mediterranean diet
- Registration Number
- NCT02131896
- Lead Sponsor
- Rabin Medical Center
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Regular nutritional instructions Control Arm- regular nutritional instructions in accordance with the accepted nutritional guidelines Regular nutritional instructions Mediterranean Diet Interventional arm-Mediterranean diet Mediterranean Diet
- Primary Outcome Measures
Name Time Method lipid profile At the end of the study-after 12 months fasting blood lipid profile
- Secondary Outcome Measures
Name Time Method Daily insulin dose At the end of the study- after 12 months Daily insulin dose adjusted for body weight
Peak stimulated C peptide At the end of the study- after 12 months Peak stimulated C peptide \> o.2 pmol/mL
Anthropometric parameters At the end of the study- after 12 months Anthropometric parameters: Body weight ,BMI SDS, body composition and weight change from diagnosis to 12 months after diagnosis
Inflammatory parameters At the end of the study-after 12 months Inflammatory parameters: TNF, CRP, IL-6, fibrinogen
Endothelial function At the end of the study-after 12 months Endothelial function: Doppler assessment of the tunica intima
weight change from at least 1 year before diagnosis to 12 months after diagnosis At the end of the study-after 12 months Metabolic control At the end of the study-after 12 months Metabolic control expressed as HbA1c level
mean and SD of blood glucose At the end of the study-after 12 months Metabolic control expressed as mean and SD of downloaded blood glucose values from patient's personal glucometer
Percent of subjects who require a daily insulin dose < o,5 IU/kg At the end of the study- after 12 months Frequency and severity of hypoglycemic episodes At the end of the study- after 12 months
Trial Locations
- Locations (1)
Schneider Children's Medical Center
🇮🇱Petah-Tikva, Israel