Atherosclerosis, Type 2 Diabetes
Conditions
Brief summary
Diabetes is an increasing cause of atherosclerotic and cardiovascular illnesses in South Korea. The clinical application of ultrasound for measuring carotid intima-media thickness, which helps in early detection and surveillance of atherosclerosis, is advancing. Due to lifestyle changes and an aging population, Koreans, especially diabetics, are developing more vascular diseases and are at higher risk for peripheral vascular disorders. Diabetics with lower limb peripheral artery disease require effective therapy to avoid major complications and a reduced quality of life. Although licensed for symptom control, Clopidogrel and Cilostazol have not yet been established for primary prevention of cardiovascular risks. These medications will be evaluated for their potential as primary preventive agents against cardiovascular disease in type 2 diabetes patients. The goal of this research is to investigate the efficacy of Cilostazol and Clopidogrel in inhibiting the progression of carotid atherosclerosis and to evaluate their influence on hemorheological changes in individuals with Type 2 diabetes. The goal of this research is to investigate the efficacy of Cilostazol and Clopidogrel in inhibiting the progression of carotid atherosclerosis and evaluating their influence on alterations in blood flow among individuals with Type 2 diabetes.
Interventions
DRUGClopidogrel
Clopidogrel 75mg once daily
DRUGCilostazol
Cilostazol 200mg per day
Sponsors
Seoul National University Bundang Hospital
Samjin Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults with diabetes aged 19 and older * Individuals with a carotid ultrasound cIMT (carotid intima-media thickness) of 1.0mm or more * Those who have not changed their combination therapy medications (including oral hypoglycemics, antihypertensives, and lipid-lowering drugs) in the last three months * Individuals with an HbA1c level of 10% or less * Those who have voluntarily signed the written consent form and agreed to participate in the study
Exclusion criteria
* Individuals currently using antithrombotic or anticoagulant medications other than aspirin * Individuals with bleeding or conditions that may increase the risk of bleeding, such as: * Hemophilia, capillary fragility, intracranial hemorrhage, upper gastrointestinal bleeding, urinary bleeding, hemoptysis, vitreous hemorrhage, etc * Active peptic ulcer, hemorrhagic stroke within the last 6 months, surgical operations within the last 3 months, proliferative diabetic retinopathy, uncontrolled hypertension * Patients who have had cerebrovascular or cardiovascular complications within the past 6 months (including stroke, transient ischemic attacks, myocardial infarction, unstable angina, coronary artery bypass graft, or percutaneous coronary intervention) * Patients with severe renal or hepatic diseases * Patients with congestive heart failure * Individuals with a history of hypersensitivity to the drug or its components * Pregnant women or women who may be pregnant * Women who are breastfeeding or plan to breastfeed during the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of carotid intima-media thickness | 52 weeks | mm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of circulation | 52 weeks | measured by ankle brachial index and laser doppler |
| Changes of HbA1c | 26 and 52 weeks | % |
| Changes of glucose | 26 and 52 weeks | mg/dL |
| Changes of body weight | 26 and 52 weeks | kg |
| Changes of whole body fat | 26 and 52 weeks | measured by bioelectrical impedance analysis |
| Changes of blood pressures | 26 and 52 weeks | systolic, diastolic (mmHg) |
| Changes of lipids | 26 and 52 weeks | total cholesterol, triglycerides, LDLc, HDLc (mg/dL) |
| Changes of peripheral pain or ischemic symptoms | 26 and 52 weeks | measured by questionnaires (visual analogue scale: 100) |
| Changes of laboratory values related to blood clot | 26 and 52 weeks | prothrombin time, activated partial thromboplastin time |
Countries
South Korea
Contacts
CONTACTSoo Lim, MD. Ph.D.
CONTACTMinji Sohn, Ph.D.
PRINCIPAL_INVESTIGATORSoo Lim, MD. Ph.D.
Seoul National University Bundang Hospital
Outcome results
None listed