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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02035891
Recruitment Status : Active, not recruiting
First Posted : January 14, 2014
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
Qifu Li, First Affiliated Hospital of Chongqing Medical University

Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: colchicine 0.5mg/d Drug: placebo 0.5mg/d Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Low-dose Colchicine Intervention in Patients With Type 2 Diabetes Mellitus and Microalbuminuria: Chongqing Study
Actual Study Start Date : December 2013
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Colchicine

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. The proportion of patients achieving at least a 15% reduction in UACR [ Time Frame: 3 years ]
    Renal outcome

  2. Changes in estimated Glomerular Filtration Rate (eGFR) [ Time Frame: 3 years ]
    Renal outcome

  3. The number of patients who have new or worsening diabetic neuropathy [ Time Frame: 3 years ]
    diabetic neuropathy was assessed based on biothesiometer.

  4. 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)

  5. changes in CIMT from baseline to the 3rd year [ Time Frame: 18 months and 3 year ]
    cardiovascular outcome

  6. 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

  7. changes of UACR [ Time Frame: 6 years ]
    evaluated at 6, 12, 18, 24, 36, 48, 60, 72 months

  8. changes of eGFR [ Time Frame: 6 years ]
    evaluated at 6, 12, 18, 24, 36, 48, 60, 72 months

  9. Death from any cause [ Time Frame: 6 years ]
    All-cause mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02035891


Locations
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China, Chongqing
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400016
Sponsors and Collaborators
Chongqing Medical University
Investigators
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Principal Investigator: Qifu Li, PhD First Affiliated Hospital of Chongqing Medical University
Publications:

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Responsible Party: Qifu Li, director of the Endocrinology Department, First Affiliated Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT02035891    
Other Study ID Numbers: CQMU-2013-QLi
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Keywords provided by Qifu Li, First Affiliated Hospital of Chongqing Medical University:
colchicine
urinary albumin-to-creatinine ratio
carotid Intima-Media Thickness
overt nephropathy
Type 2 diabetes
Additional relevant MeSH terms:
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Kidney Diseases
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents