Type 2 Diabetes Mellitus Clinical Trial
Official title:
Effect of Cilostazol, a Phosphodiesterase 3 Inhibitor, on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes
| Verified date | April 2020 |
| Source | Seoul National University Bundang Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To investigate the effect of cilostazol compared with aspirin on carotid atherosclerosis in patients with type 2 diabetes mellitus
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | December 31, 2019 |
| Est. primary completion date | October 21, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 30 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Age between 30 and 80 years - Patients with type 2 diabetes on treatment (HbA1c 6.0-11.0%) - Carotid plaque on 3D ultrasound Exclusion Criteria: - Acute bleeding or bleeding tendency - Diagnosed with heart failure - Suggestive of ischemia on ECG - Uncontrolled hypertension - Recently diagnosed with peptic ulcer disease - Taking other antiplatelet agents - Hypersensitivity to salicylic acid - Aspirin induced asthma - Severe kidney, liver, heart disease |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Gyeonggi |
| Lead Sponsor | Collaborator |
|---|---|
| Seoul National University Bundang Hospital |
Korea, Republic of,
Huh JH, Seok H, Lee BW, Kang ES, Lee HC, Cha BS. Effect of cilostazol on carotid intima-media thickness in type 2 diabetic patients without cardiovascular event. Endocrine. 2014 Sep;47(1):138-45. doi: 10.1007/s12020-013-0120-y. Epub 2014 Jan 1. — View Citation
Katakami N, Kim YS, Kawamori R, Yamasaki Y. The phosphodiesterase inhibitor cilostazol induces regression of carotid atherosclerosis in subjects with type 2 diabetes mellitus: principal results of the Diabetic Atherosclerosis Prevention by Cilostazol (DAPC) study: a randomized trial. Circulation. 2010 Jun 15;121(23):2584-91. doi: 10.1161/CIRCULATIONAHA.109.892414. Epub 2010 Jun 1. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Glucose metabolism 1 | HOMA-Insulin Resistance | 6 months | |
| Other | Diabetic complication | Albuminuria | 6 months | |
| Other | Glucose metabolism 2 | HbA1c | 6 months | |
| Other | Body composition | Body fat mass and percent | 6 months | |
| Primary | Change of carotid artery atherosclerosis | Plaque composition | 6 months | |
| Secondary | Change of carotid artery atherosclerosis 1 | Changes in carotid intima-media thickness after treatment | 6 months | |
| Secondary | Change of carotid artery atherosclerosis 2 | Changes in carotid artery stenosis after treatment | 6 months | |
| Secondary | Change of carotid artery atherosclerosis 3 | Plaque volume in carotid artery | 6 months |
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