Prospective, randomized, open-label, clinical trial evaluating the effects of vildagliptin on progression of atherosclerotic plaques in type 2 diabetic patients
- Conditions
- type 2 diabetes
- Registration Number
- JPRN-UMIN000011746
- Lead Sponsor
- Makoto Ayaori
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 176
Not provided
1) Allergy against vildagliptin 2) Type 1 diabetes or secondary diabetes 3) Under administration of DPP-4 inhibitors 4) Patients with diabetic retinopathy who need or underwent light coagulation and vitreous surgery for diabetic retinopathy within 1 year 5) History of stroke, acute coronary syndrome or any cardiovascular diseases needed for inpatient-treatments within 6 months 6) Either level of aspartate aminotransaminase or alanine aminotransferase exceeds three-fold of the normal limits 7) End stage renal disease 8) Symptomatic (NYHA III or IV) congestive heart failure 9) Malignancies or other diseases with poor prognosis 10) Pregnant 11) Severe infectious/traumatic diseases 12) Subjects whose doctor in charge do not agree to join the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method (1) Carotid atherosclerosis evaluated by ultrasound (Intima-media thickness; IMT (meanIM/maxIMT) and plaque score) (2) Area and thickness of atherosclerotic plaques in aorta detected by magnetic resonance imaging (MRI) 12/24 months after randomization
- Secondary Outcome Measures
Name Time Method (1) Flow-mediated vasodilation in forearm (2) ankle/brachial index and cardio ankle vascular index (3) Markers for diabetes (hemoglobin A1c, glycoalbumin, blood glucose) (4) Serum lipids (5) Markers indicating obesity (e.g. adiponectin) (6) Markers indicating inflammation (e.g. high sensitive CRP) (7) Markers indicating oxidative stress (8-OHdG/ MDA-LDL) (8) Markers indicating chronic renal diseases (urine albumin/L-FABP) (9) Blood/urine urate levels (10) body weight/waist circumference (11) blood pressures