Diabetes mellitus Nutritional, Metabolic, Endocrine
Conditions
Interventions
This is an interventional study, in which a nutritional supplement will be used in a group of diabetic patients treated with antidiabetic tablets, who will receive the supplement in question alongside
Sponsors
University of Crete
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible participants will be type II diabetes patients treated with antidiabetic tablets, with an age over 50 years who belong to the registered population of responsibility of the 4th Local Health Unit (TOMY) of Heraklion.
Exclusion criteria
Exclusion criteria: Highly vulnerable individuals will be excluded, following the relevant legal and ethical rules. The above cases are also excluded: 1. Gestational diabetes (breastfeeding/pregnancy), 2. Maturity-onset diabetes of the young (MODY), 3. Pancreatogenic diabetes (T3CDM), 4. Heart, liver or kidney disease, 5. Serious psychiatric illness or addiction, 6. Patients with comorbidities such as cancer, AIDS, neoplastic diseases, 7. Organ transplant patients, patients under immunosuppressive therapy, 8. Patients who have recently suffered a cardiovascular event, within three months before the start of the study, 9. Patients using other antioxidant supplementations, 10. Patients with a requirement for long-term use of aspirin, other than low dosage for protection against cardiovascular events, or NSAIDs, 11. Patients participating in another interventional clinical study, 12. Patients with planned surgery or other interventional procedure requiring systemic anesthesia during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Telomere length will be measured using quantitative Polymerase Chain Reaction (qPCR), before (t=0) and after the intervention (t=32 weeks) for both groups | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. [CBC] measured using [Beckman Coulter method of counting and sizing], before and after the intervention for both study groups 2. [IL-6] measured using [electrochemiluminescence] before and after the intervention for both study groups 3. [reticulocytes] measured using [Methylene blue stain (NMB)] before and after the intervention for both study groups 4. [hemoglobin] measured using [Beckman Coulter method of counting and sizing] before and after the intervention for both study groups 5. [WBC] measured using [Beckman Coulter method of counting and sizing] before and after the intervention for both study groups 6. [CRP] measured using [latex indirect agglutination (LIA)] before and after the intervention for both study groups 7. [HbA1c] measured using [high-performance liquid chromatography (HPLC)] before and after the intervention for both study groups 8. [TC] measured using [enzymatic method] before and after the intervention for both study groups 9. [LDL] measured using [Friedewald calculation] before and after the intervention for both study groups 10. [TGL] measured using [GPO/POD] before and after the intervention for both study groups 11. [creatinine] measured using [Creatinine amidohydrolase enzymatic method] before and after the intervention for both study groups 12. [serum nitrogen] measured using [Nesslerization] before and after the intervention for both study groups 13. [DHEAS] measured using [DHEA Sulfate Test] before and after the intervention for both study groups, 14. [25-OH-vitamin D] measured using [immunoassay, Liaison 25(OH) Vitamin D Total assay] before and after the intervention for both study groups 15. [FEV1] measured using piko-spirometry before and after the intervention for both study groups | — |
Countries
Greece
Outcome results
None listed