Biologiccal aging Biologiccal aging
Conditions
Interventions
After obtaining consent and allocation, the study drug group will take one 10 mg tablet of the study drug once a day after breakfast. If the attending physician deems it necessary, the following chang
SGLT2 inhibitor
Sponsors
Minamino Tohru
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Those who meet one of the following conditions at the time of obtaining consent. 1-1. Those aged 75 years or older 1-2. Those aged 65 years or older and with cognitive decline (MMSE score less than 27 points) 1-3. Those aged 65 years or older and with frailty (clinical frailty scale score of 4 or higher) 2. Those who have been diagnosed with diabetes, chronic heart failure, or chronic kidney disease 3. Those who have received a full explanation of their participation in this study, fully understood the contents, and freely provided written consent to participate.
Exclusion criteria
Exclusion criteria: 1. Those taking SGLT2 inhibitors at the time of the eligibility test 2. Those who have been administered SGLT2 inhibitors within 24 weeks prior to the eligibility test 3. Those with a history of hypersensitivity to SGLT2 inhibitors 4. Those with a history of diabetic ketoacidosis, diabetic coma, or hypoglycemic attack (hypoglycemia requiring third-party intervention or persistent hypoglycemia) within 24 weeks prior to the eligibility test 5. Those with severe infection or serious trauma at the time of eligibility testing 6. Those expected to undergo surgery within one year at the time of eligibility testing 7. Those with NYHA class IV heart failure 8. Those with severe renal dysfunction (eGFR less than 30mL/min/1.73m2 within 3 months of consent or undergoing dialysis) 9. Those with severe liver dysfunction (AST or ALT values 3 times or more higher than the facility standard within 3 months of consent) 10. Those with pituitary or adrenal insufficiency 11. Those who are malnourished, starving, have irregular eating habits, or are in a state of insufficient food intake or are in a state of weakness 12. Those who have a history of excessive alcohol intake (average of 100g or more of ethanol per day) 13. Those who have intestinal disorders such as diarrhea or vomiting at the time of the eligibility test and are considered to be prone to dehydration 14. Those who recieve treatment for a urinary tract infection or genital infection at the time of the eligibility test 15. Those who are pregnant or may be pregnant at the time of the eligibility test, those who are breastfeeding, and those who wish to become pregnant while participating in this study 16. Those with a BMI of less than 18.5 kg/m2 at the time of the eligibility test 17. Those who have a history of infection or trauma, hospitalization within 4 weeks prior to the eligibility test, or those with malignant tumors or other serious diseases that are in remission at the time of the eligibility test 18. Those who are otherwise deemed unsuitable as study subjects by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Changes in biological age calculated using the epigenetic aging clock method based on DNA methylation patterns in peripheral blood leukocytes before and after the intervention (GrimAge version2) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in biological age before and after intervention using the "Phenotypic Age Calculator" 2. Hospitalization for any cause 3. All-cause mortality 4. Change in grip strength and walking speed (SPPB) 5. Change in skeletal muscle mass and bone mineral mass (DEXA) 6. Change in eGFR 7. Change in NTproBNP 8. Change in HbA1c 9. Change in MMSE score 10. Changes in biological age calculated using other epigenetic aging clock method based on DNA methylation patterns in peripheral blood leukocytes before and after the intervention (Horvath's Aging Clock, Hannum's clock (v1,v2), Lin's clock, EpiToc Clock, PhenoAge, GrimAge (version 1), DunedinPACE (DunedinPoAm), Pan-Mammalian Clocks, DeepMAge, DNAmTL) | — |
Contacts
Public ContactGoro Katsuumi
Department of Cardiovascular Biology and Medicine Juntendo University School of Medicine
Outcome results
None listed