Using SGLT2 inhibitors to reduce aging effects in patients with diabetes and heart disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

\<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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.