Low-dose Colchicine in Patients With Type 2 Diabetes Mellitus and Microalbuminuria

• Status: Active, not recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

1. The primary objective of this study was： in patients with type 2 diabetes and microalbuminuria who have been receiving stable treatment of angiotensin-converting enzyme inhibitor/angiotensin II receptor blocker (ACEI/ARB) for at least 3 months, whether low-dose colchicine slows the progression of microvascular complications.

2. The secondary objective of this study was： (1) whether low-dose colchicine could reduce Urinary Albumin To Creatinine Ratio (UACR), or improve eGFR in patients with type 2 diabetes and microalbuminuria; (2) whether low-dose colchicine decreases carotid intima-media thickness(IMT) in patients with type 2 diabetes and microalbuminuria; (3) whether low-dose colchicine reduces the risk of cardiovascular events or mortality in patients with type 2 diabetes and microalbuminuria.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chongqing Medical University
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• Well informed of the procedures of this trial and informed consent is obtained

• Voluntarily accept standardized treatment

• 30-70 years old, gender is not limited

• Diagnosed as type 2 diabetes and have received standardized hypoglycemic therapy

• Have been receiving stable doses of ACEI or ARBs for at least 3 months

• Two of three examinations of UACR at random urine are 30-300 mg/g Cr (infection or other factors were ruled out) in 3 months

• Well compliance

• Capable of self blood Glucose monitoring

Exclusion Criteria:

• Pregnant or lactating

• Type 1 diabetes

• Poor blood glucose control（HbA1c>11%）

• A history of malignant tumor

• Abnormal liver or renal function (defined as alanine aminotransferase(ALT)>2.5 times higher than normal range,or eGFR<30 mL/min per 1•73 m²)

• Poor blood pressure control [systolic blood pressure(SBP)>180mmHg,or diastolic blood pressure(DBP)>110mmHg]

• With severe heart disease,cardiac function worse than grade II,anemia(Hb<9.0g/d1)

• Continuous use of colchicine or non-steroidal anti-inflammatory drugs (except aspirin) more than one week in recent 3 months

• History of gout

• Blood routine test indicates that the white blood cell count(WBC) <3*109/l

• Body Mass Index(BMI)<18.5 or ≥35kg/m2

• Drug or alcohol abuse

• Accompanying mental disorder who can't collaborate

• Abnormal digestion and absorption function

• Other endocrine diseases

• Other chronic diseases needed long-term glucocorticoid treatment

• With severe infection, immune dysfunction

• A history of colchicine allergies or allergic constitution