Arterial stiffness in patients with diabetes mellitus Arterial stiffnes, cardio-ankle vascular index, CAVI, colchicine
Conditions
Interventions
One tablet of 0.6 mg colchicine per day for 6 months,One tablet of placebo per day for 6 months
Active Comparator Drug,Placebo Comparator Drug
Sponsors
Faculty of Medicine, Prince of Songkhla University
Eligibility
Sex/Gender
All
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Type 2 diabetes melitus 2. Met one of the following conditions: hyperlipidemia, hypertension, obesity defined as BMI greater than 25 kg/m2 or a waist circumference greater than 90 cm in males, or 80 cm in females
Exclusion criteria
Exclusion criteria: 1. Diabetic patients using insulin or had significant proteinuria 2. History of heart failure, or documented left ventricular ejection fraction less than 50% 3. Coronary artery diseases 4. History of myocardial infarction, ischemic stroke, peripheral arterial disease 5. Recent smoking within 1 year prior to enrollment 6. Hypertensive or diabetic medications were recent adjusted in previous 3 months prior to enrollment 7. Atrial fibrillation 8. Pateints with untreated, being treated malignancy, or evidence of tumor recurrence within 5 years 9. History of inflammatory bowel disease 10. Patients with chronic diarrhea 11. History of neuromuscular disease 12. Patients with cirrhosis or chronic hepatitis viral infection or severe liver dysfunction 13. Elevated liver enzyme greater than 3 times of upper reference value 14. Creainine clearance less than 50 ml/min 15. Hemoglobin level less than 10 g/dL, or white blood cells less than 3,000 /mm3, or platelets less than 110,000 /mm3 16. Patients with HIV infection 17. History of colchicine use in previous 1 month before enrollment 18. Patients with suspected fungal infection or being treated with angifungal drugs 19. Female with planned or being pregnancy or breastfeeding within 1 year 20. History of colchicine allergy 21. Patients with ongoing or planned treatment with steroids 22. Concurrent medications affecting to colchicine e.g. macrolides, antifungal medication (azole group, griseofulvin), verapamil, diltiazem, high dose simvastatin and atorvastatin 23. Patients taking strong CYP3A4 inhibitors 24. Elevated creatinine phosphokinase greater than 3 times of upper reference value 25. Patients is participating other research program
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Arterial stiffness Before starting intervention and at 6 months after end of the intervention Cardio-ankle vascular index (CAVI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Systemic inflmmation Before starting intervention andAt 6 months after end of the intervention Serum erythrocyte sedimentation rate, C-reactive protein, interleukin-6,Myocardial injury Before starting intervention andAt 6 months after end of the intervention Serum troponin T | — |
Countries
Thailand
Contacts
Public ContactTHANAPON NILMOJE
Prince of Songklanagarind University
Outcome results
None listed