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

January 29, 2019 updated by: Qifu Li, Chongqing Medical University

Low-dose Colchicine Intervention in Patients With Type 2 Diabetes Mellitus and Microalbuminuria: Chongqing Study

  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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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, control study, aims at evaluating microvascular events from date of randomization until the third year. Other parameters included evaluating changes of UACR, eGFR, CIMT from baseline to the follow-up.
  • Phases 2: A prospective observational 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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: colchicine
0.5mg/d colchicine
Drug: colchicine 0.5mg/d
on the basis of standard therapy to manage hyperglycemia, hypertension,dislipidemia etc.
Placebo Comparator: placebo
appearance is same as colchicine
Drug: placebo 0.5mg/d
on the basis of standard therapy to manage hyperglycemia, hypertension,dislipidemia etc.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of overt nephropathy
Time Frame: 3 years
overt nephropathy is defined as any one of the events described below: （1） UACR greater than 300 mg/g Cr; (2) 24 h urinary albumin greater than 300 mg; (3)doubling of the serum creatinine level to at least 200 μmol per liter; (4)the need for renal-replacement therapy;(5) death due to renal disease.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients achieving at least a 15% reduction in UACR
Time Frame: 3 years
Renal outcome
3 years
Changes in estimated Glomerular Filtration Rate (eGFR)
Time Frame: 3 years
Renal outcome
3 years
The number of patients who have new or worsening diabetic neuropathy
Time Frame: 3 years
diabetic neuropathy was assessed based on biothesiometer.
3 years
The number of patients who have new or worsening diabetic retinopathy
Time Frame: 3 years
Diabetic retinopathy was diagnosed according to the six-level grading scale of the European Community- funded Concerted Action Programme into the Epidemiology and Prevention of Diabetes (EURODIAB)
3 years
changes in CIMT from baseline to the 3rd year
Time Frame: 18 months and 3 year
cardiovascular outcome
18 months and 3 year
The number of patients who have new cardiovascular events
Time Frame: 6 years
cardiovascular events include death from cardiovascular causes, nonfatal stroke, nonfatal myocardial infarction, coronary-artery bypass grafting, percutaneous coronary intervention or revascularization for peripheral atherosclerotic arterial disease, and amputation because of ischemia
6 years
changes of UACR
Time Frame: 6 years
evaluated at 6, 12, 18, 24, 36, 48, 60, 72 months
6 years
changes of eGFR
Time Frame: 6 years
evaluated at 6, 12, 18, 24, 36, 48, 60, 72 months
6 years
Death from any cause
Time Frame: 6 years
All-cause mortality
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing Medical University

Investigators

  • Principal Investigator: Qifu Li, PhD, First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2013

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

January 4, 2014

First Submitted That Met QC Criteria

January 11, 2014

First Posted (Estimate)

January 14, 2014

Study Record Updates

Last Update Posted (Actual)

January 31, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CQMU-2013-QLi

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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