Status:
UNKNOWN
Effect of Sodium-glucose Cotransporter-2 Inhibitor in Cellular Senescence in Patients With Cardiovascular Diseases or Type 2 Diabetes
Lead Sponsor:
Yonsei University
Conditions:
Diabetes Mellitus
Cellular Senescence
Eligibility:
All Genders
50-85 years
Phase:
PHASE4
Brief Summary
Patients with type 2 diabetes (T2D) are more prevalent with aging-related comorbidities and frailty, which leads to a shorter life expectancy than non-diabetic individuals and that this excess mortali...
Detailed Description
\<Study design\> * Prospective study : Patients with type 2 diabetes who started antidiabetics for the first time or were taking antidiabetics (metformin-based monotherapy or 2- or 3- agent therapy),...
Eligibility Criteria
Inclusion
- \<Inclusion criteria for patients with type 2 diabetes and high risk cardiovascular disease\>
- Patients with type 2 diabetes who meet the diagnostic criteria of standard practice guidelines
- Age between 50 and 85
- Patients who signed the consent form
- 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\>
- Adults 19 years of age or older who do not meet the diagnostic criteria for metabolic syndrome, diabetes, or hyperlipidemia
- Patients not taking medications related to diabetes or hyperlipidemia
- BMI less than 25kg/m2
- \<Exclusion criteria\>
- Those who are unable to participate in clinical trials due to other researchers' judgment
- Those who cannot read the consent form
- Patients who refused to fill out the research participation consent form
- Breastfeeding or pregnant women
- Type 1 diabetes
- adrenal insufficiency, growth hormone deficiency, pituitary disease
- Patients who have undergone bariatric surgery within the past 2 years or gastrointestinal surgery that can cause chronic malabsorption
- Patients who have taken anti-obesity drugs within the past month or who have received other treatments that can cause weight changes
- Patients with blood diseases that can cause hemolysis or abnormal red blood cells
- Patients with active cancer or undergoing chemotherapy
- Patients with liver disease and cirrhosis who are taking antiviral drugs
- Patients with autoimmune disease taking steroids and immunosuppressants
- Organ transplant patients
- Taking antibiotics or NSAIDs within the last 2 weeks
- Patients with acute infections in previous 3 months including COVID-19
- Previous use of GLP-1 receptor agonist, thiazolidinedione, SGLT2 inhibitor
- Patients with severe hyperglycemia (HbA1c \> 10%)
Exclusion
Key Trial Info
Start Date :
June 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT05975528
Start Date
June 1 2023
End Date
December 31 2025
Last Update
May 9 2024
Active Locations (1)
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1
Yonsei University College of Medicine
Seoul, South Korea