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Clinical Trial Details

Trial ID: L6916
Source ID: NCT05975528
Associated Drug: Sglt2 Inhibitor
Title: Effect of Sodium-glucose Cotransporter-2 Inhibitor in Cellular Senescence in Patients With Cardiovascular Diseases or Type 2 Diabetes
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus|Cellular Senescence|Sodium-Glucose Transporter 2 Inhibitors
Interventions: DRUG: SGLT2 inhibitor|DRUG: Glimepiride
Outcome Measures: Primary: Changes of Cellular senescence markers, Changes of cellular senescence markers (CD57+CD28- T cell, CD87+ monocyte) between SGLT2 inhibitor users and glimepiride users, Changes from baseline to 3 months after use of SGLT2 inhibitors | Secondary: Changes of Senescence-associated secretory phenotype, SASP (Senescence-associated secretory phenotype) : IL-1/6, TNFa, MCP-1, Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors|Changes of biochemistry profiles in blood (10^3/μL), - Changes in Biochemistry profiles in blood WBC count (10\^3/μL), Platelet counts (10\^3/μL), Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors|Changes of biochemistry profiles in blood (g/dL), - Changes in Biochemistry profiles in blood Hemoglobin (g/dL), Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors|Changes of biochemistry profiles in blood (%), - Changes in Biochemistry profiles in blood Hematocrit (%), HbA1c (%), Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors|Changes of biochemistry profiles in blood (mg/dL), - Changes in Biochemistry profiles in blood Creatinine (mg/dL), Total cholesterol (mg/dL), Triglyceride (mg/dL), HDL-cholesterol (mg/dL), Fasting glucose (mg/dL), Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors|Changes of biochemistry profiles in blood (IU/L), - Changes in Biochemistry profiles in blood AST (IU/L), ALT (IU/L), γ-Glutamyl transferase (IU/L), Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors|Changes of biochemistry profiles in blood (mg/L), - Changes in Biochemistry profiles in blood C-Reactive Protein(mg/L), Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors|Changes of biochemistry profiles in blood (μEq/L), - Changes in Biochemistry profiles in blood Free fatty acid-Fasting (μEq/L), Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors|Changes of biochemistry profiles in blood (μU/mL), - Changes in Biochemistry profiles in blood Fasting Insulin (μU/mL), Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors|Changes of biochemistry profiles in blood (mmol/L), - Changes in Biochemistry profiles in blood Beta-hydroxybutyrate (mmol/L), Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors|Changes of body composition using Inbody (kg), Changes of body composition using Inbody: Skeletal muscle mass (kg) Body fat mass (kg) Right arm muscle mass (kg) Left arm muscle mass (kg) Trunk muscle mass (kg) Right leg muscle mass (kg) Left leg muscle mass (kg), Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors|Changes of body composition using Inbody (cm), Changes of body composition using Inbody: Weight circumference (cm) Hip circumference (cm), Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors|Changes of body composition using Inbody (cm2), Changes of body composition using Inbody: Visceral fat area (cm2), Changes from baseline to 3 months/6 months after use of SGLT2 inhibitors
Sponsor/Collaborators: Sponsor: Yonsei University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 92
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-06-01
Completion Date: 2025-12-31
Results First Posted:
Last Update Posted: 2024-05-09
Locations: Yonsei University College of Medicine, Seoul, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT05975528