Effect of low-dose colchicine on arterial stiffness assessed by cardio-ankle vascular index in patients with diabetes mellitus
- Conditions
- Arterial stiffness in patients with diabetes mellitusArterial stiffnes, cardio-ankle vascular index, CAVI, colchicine
- Registration Number
- TCTR20211110002
- Lead Sponsor
- Faculty of Medicine, Prince of Songkhla University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Arterial stiffness Before starting intervention and at 6 months after end of the intervention Cardio-ankle vascular index (CAVI)
- Secondary Outcome Measures
Name Time Method 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