Type 1 Diabetes
Conditions
Keywords
Type 1 Diabetes, Newly diagnosed, Lipid profile, Mediterranean diet
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
Interventions
OTHERInterventional arm-Mediterranean diet
OTHERControl Arm- regular nutritional instructions in accordance with the accepted nutritional guidelines
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| lipid profile | At the end of the study-after 12 months | fasting blood lipid profile |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Peak stimulated C peptide | At the end of the study- after 12 months | Peak stimulated C peptide \> o.2 pmol/mL |
| Daily insulin dose | At the end of the study- after 12 months | Daily insulin dose adjusted for body weight |
| Percent of subjects who require a daily insulin dose < o,5 IU/kg | 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 |
| 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 |
| weight change from at least 1 year before diagnosis to 12 months after diagnosis | At the end of the study-after 12 months | — |
| 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 |
| Frequency and severity of hypoglycemic episodes | At the end of the study- after 12 months | — |
Countries
Israel
Outcome results
None listed