Using SGLT2 inhibitors to reduce aging effects in patients with diabetes and heart disease
Effect of Sodium-glucose Cotransporter-2 Inhibitor in Cellular Senescence in Patients With Cardiovascular Diseases or Advanced Type 2 Diabetes
This study is testing if a diabetes medication can help people with diabetes and heart disease feel younger and healthier over six months.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05975528 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of sodium-glucose cotransporter 2 (SGLT2) inhibitors on cellular senescence in patients with type 2 diabetes and cardiovascular diseases. It involves a prospective design where participants will receive either SGLT2 inhibitors or non-SGLT2 medications over a 180-day period, with blood samples collected for analysis. The goal is to assess whether SGLT2 inhibitors can mitigate aging-related comorbidities and improve overall health outcomes in this population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 50 to 85 with type 2 diabetes and high-risk cardiovascular conditions.
Not a fit: Patients without type 2 diabetes or those who do not meet the high-risk criteria for cardiovascular disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the health and longevity of patients with type 2 diabetes and cardiovascular diseases.
How similar studies have performed: Previous studies have shown promising results with SGLT2 inhibitors in metabolic diseases, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
\<Inclusion criteria for patients with type 2 diabetes and high risk cardiovascular disease\> 1. Patients with type 2 diabetes who meet the diagnostic criteria of standard practice guidelines 2. Age between 50 and 85 3. Patients who signed the consent form 4. Patients who meet at least one of the following as a high-risk group for cardiovascular disease: 1) History of myocardial infarction, within the last 3 months 2) Imaging proven coronary artery disease (2 or more coronary arteries or left main coronary artery disease) 3) History of ischemic or hemorrhagic cerebrovascular disease within the last 3 months 4) Imaging proven obstructive peripheral arterial disease 5) Intima media thickness more than 0.9mm or observed plaque 6) estimated glomerular filtration rate between 30-60 7) BMI more than 25kg/m2 accompanied two or more of the following are present: hypertension, current smoker, imaging proven steatohepatitis, alanine aminotransferase more than 40IU/L \<Inclusion criteria for healthy people\> 1. Adults 19 years of age or older who do not meet the diagnostic criteria for metabolic syndrome, diabetes, or hyperlipidemia 2. Patients not taking medications related to diabetes or hyperlipidemia 3. BMI less than 25kg/m2 \<Exclusion criteria\> 1. Those who are unable to participate in clinical trials due to other researchers' judgment 2. Those who cannot read the consent form 3. Patients who refused to fill out the research participation consent form 4. Breastfeeding or pregnant women 5. Type 1 diabetes 6. adrenal insufficiency, growth hormone deficiency, pituitary disease 7. Patients who have undergone bariatric surgery within the past 2 years or gastrointestinal surgery that can cause chronic malabsorption 8. Patients who have taken anti-obesity drugs within the past month or who have received other treatments that can cause weight changes 9. Patients with blood diseases that can cause hemolysis or abnormal red blood cells 10. Patients with active cancer or undergoing chemotherapy 11. Patients with liver disease and cirrhosis who are taking antiviral drugs 12. Patients with autoimmune disease taking steroids and immunosuppressants 13. Organ transplant patients 14. Taking antibiotics or NSAIDs within the last 2 weeks 15. Patients with acute infections in previous 3 months including COVID-19 16. Previous use of GLP-1 receptor agonist, thiazolidinedione, SGLT2 inhibitor 17. Patients with severe hyperglycemia (HbA1c \> 10%)
Where this trial is running
Seoul
- Yonsei University College of Medicine — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Yong-ho Lee — Department of Internal medicine, Yonsei University College of Medicine
- Study coordinator: Yong-ho Lee
- Email: YHOLEE@yuhs.ac
- Phone: 02-2228-9143
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.