Effect of Sodium-glucose Cotransporter-2 Inhibitor in Cellular Senescence in Patients With Cardiovascular Diseases or Type 2 Diabetes

• Register: ClinicalTrials.gov
• Last refreshed on: 13 May 2024
• Main ID: NCT05975528
• Date of registration: 13/06/2023
• Prospective Registration: No
• Primary sponsor: Yonsei University
• Public title: Effect of Sodium-glucose Cotransporter-2 Inhibitor in Cellular Senescence in Patients With Cardiovascular Diseases or Type 2 Diabetes
• Scientific title: Effect of Sodium-glucose Cotransporter-2 Inhibitor in Cellular Senescence in Patients With Cardiovascular Diseases or Advanced Type 2 Diabetes
• Date of first enrolment: June 1, 2023
• Target sample size: 92
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT05975528
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

Korea, Republic of

Contacts

• Name: Yong-ho Lee

• Name: Yong-ho Lee

• Name: Yong-ho Lee
• Affiliation: Department of Internal medicine, Yonsei University College of Medicine

Key inclusion & exclusion criteria

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



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



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%)



Age minimum: 50 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus

Sodium-Glucose Transporter 2 Inhibitors

Cellular Senescence

Intervention(s)

Drug: SGLT2 inhibitor

Drug: Glimepiride

Primary Outcome(s)

Changes of Cellular senescence markers [Time Frame: Changes from baseline to 3 months after use of SGLT2 inhibitors]

Secondary Outcome(s)

Changes of biochemistry profiles in blood (µEq/L) [Time Frame: Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors]

Changes of biochemistry profiles in blood (IU/L) [Time Frame: Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors]

Changes of biochemistry profiles in blood (mmol/L) [Time Frame: Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors]

Changes of body composition using Inbody (cm) [Time Frame: Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors]

Changes of biochemistry profiles in blood (%) [Time Frame: Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors]

Changes of body composition using Inbody (kg) [Time Frame: Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors]

Changes of biochemistry profiles in blood (g/dL) [Time Frame: Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors]

Changes of biochemistry profiles in blood (mg/dL) [Time Frame: Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors]

Changes of body composition using Inbody (cm2) [Time Frame: Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors]

Changes of biochemistry profiles in blood (10^3/µL) [Time Frame: Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors]

Changes of biochemistry profiles in blood (µU/mL) [Time Frame: Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors]

Changes of biochemistry profiles in blood (mg/L) [Time Frame: Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors]

Changes of Senescence-associated secretory phenotype [Time Frame: Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors]

Secondary ID(s)

4-2022-1483

Source(s) of Monetary Support

Please refer to primary and secondary sponsors