ISRCTN13131584ISRCTN17/01/2023University of CreteStudy on the benefit of quercetin intake in diabetic patients treated with antidiabetic tablets.Study on the benefit of quercetin intake in diabetic patients treated with antidiabetic tablets. A two-arm, prospective randomized control clinical trial (interventional vs observation group) in primary health care.07/02/2023Actual100No longer recruitinghttps://www.isrctn.com/ISRCTN13131584InterventionalInterventional randomized controlled clinical trial (Other)Not ApplicableDiabetes mellitusThis 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 their treatment (intervention group) and a group which will not be administered to the nutritional supplement alongside the treatment (control group). The nutritional supplement that will be administered is quercetin. The time and dosage of supplementation of quercetin will respect the indications of the nutritional supplement. Specifically, the intervention group will be given 500 mg of quercetin per day for 12 weeks, which will then be ceased for 8 weeks and re-administered for another 12 weeks. A random allocation ratio will be used for the recruitment of the patients in the intervention and control group, taking into account age and gender.10029/01/2024https://pubmed.ncbi.nlm.nih.gov/39338301/, https://pubmed.ncbi.nlm.nih.gov/38745810/, https://pubmed.ncbi.nlm.nih.gov/38930033/05/02/2025YesNot expected to be made available. The datasets generated during and/or analysed during the current study are not expected to be made available due to the sensitivity of the genetic, bioclinical and personal data of study participants.
Public
Scientific
GreeceEligible 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.50 YearsAllHighly 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.Nutritional, Metabolic, EndocrineSupplementTelomere length will be measured using quantitative Polymerase Chain Reaction (qPCR), before (t=0) and after the intervention (t=32 weeks) for both groups1. [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 groups2934/253Protocol serial numberInvestigator initiated and fundedApproved 20/08/2021, University of Crete Research Ethics Committee (Rectors Office, University of Crete, Voutes University Campus Heraklion, Crete, 71300, Greece; +302810395206; ehde@uoc.gr), ref: 104/20.08.2021.