Overview

This trial is active, not recruiting.

Condition diabetic nephropathy
Treatments colchicine 0.5mg/d, placebo 0.5mg/d
Sponsor Chongqing Medical University
Start date December 2013
End date June 2018
Trial size 160 participants
Trial identifier NCT02035891, CQMU-2013-QLi

Summary

The study aims to assess:

1. whether low-dose colchicine could reduce microalbuminuria 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;

2. whether low-dose colchicine decreases carotid intima-media thickness(IMT) in patients with type 2 diabetes and microalbuminuria;

3. whether low-dose colchicine slows the progression of microvascular complications in patients with type 2 diabetes and microalbuminuria;

4. whether low-dose colchicine reduces the risk of cardiovascular events in patients with type 2 diabetes and microalbuminuria.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Active Comparator)
0.5mg/d colchicine
colchicine 0.5mg/d
on the basis of standard therapy to manage hyperglycemia, hypertension,dislipidemia etc.
(Placebo Comparator)
appearance is same as colchicine
placebo 0.5mg/d
on the basis of standard therapy to manage hyperglycemia, hypertension,dislipidemia etc.

Primary Outcomes

Measure
changes in UACR from baseline to the sixth month.
time frame: 6 months
changes in CIMT from baseline to the 18th month
time frame: 18 months
incidence of overt nephropathy
time frame: 3 years
composite cardiovascular events
time frame: 6 years

Secondary Outcomes

Measure
Changes in 24 h urinary albumin
time frame: 6 months
The proportion of patients achieving at least a 15% reduction in UACR
time frame: 6 months
Changes in estimated Glomerular Filtration Rate (eGFR)
time frame: 6 months
New or worsening diabetic neuropathy
time frame: 3 years
New or worsening diabetic retinopathy
time frame: 3 years
Death from any cause
time frame: 6 years
Each component of primary outcomes of phase4
time frame: 6 years
Overt nephropathy
time frame: 6 years
New or worsening diabetic neuropathy
time frame: 6 years
New or worsening diabetic retinopathy
time frame: 6 years

Eligibility Criteria

Male or female participants from 30 years up to 70 years old.

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

Additional Information

Official title Low-dose Colchicine Intervention in Patients With Type 2 Diabetes Mellitus and Microalbuminuria: Chongqing Study
Principal investigator Qifu Li, PhD
Description BACKGROUND—Previous study reported that colchicine 0.5 mg/day, in addition to statins and other standard secondary prevention therapies, was effective for the prevention of cardiovascular events in patients with stable coronary disease. An experiment conducted by Li et al. showed that twenty-four-hour urinary albumin excretion was reduced after 6 months colchicine treatment in rats with diabetic nephropathy.As both micro and macrovascular complications of diabetes are closely associated with inflammation,with the anti-inflammation property,colchicine might reduce risk for micro and macrovascular complications of diabetes. STUDY DESIGN—Patients with type 2 diabetes and microalbuminuria(30mg/g Cr≤UACR≤300mg/g Cr) who have received stable dosage of ACEI/ARB for at least 3 months will be randomized to receive colchicine 0.5 mg/day or placebo. This trial includes four phases: - Phases 1: A prospective, randomized,double-blind,placebo control study,aims at evaluating changes of Urinary Albumin To Creatinine Ratio(UACR) from baseline to the 6th month. - Phases 2: A prospective, randomized,double-blind,placebo control study,aims at evaluating changes of CIMT from baseline to the 18th month. - Phases 3: A prospective, randomized,double-blind,control study,aims at evaluating microvascular events from date of randomization until the third year. - Phases 4: A prospective, randomized,double-blind,control study, aims at evaluating macrovascular and microvascular events from date of randomization until the 6th year. SAFETY AND DATA MANAGEMENT-Independent Safety and Data Monitoring Committee has been set up to monitor the safety and tolerability of the subjects; this committee will analyze data independent of investigators at the end of any one phase.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Chongqing Medical University.