NCT02035891

Brief Summary

  1. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 4, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

5.8 years

First QC Date

January 4, 2014

Last Update Submit

January 29, 2019

Conditions

Diabetic Nephropathy

Keywords

colchicineurinary albumin-to-creatinine ratiocarotid Intima-Media Thicknessovert nephropathyType 2 diabetes

Outcome Measures

Primary Outcomes (1)

  • The incidence of overt nephropathy

    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 Outcomes (9)

  • The proportion of patients achieving at least a 15% reduction in UACR

    3 years

  • Changes in estimated Glomerular Filtration Rate (eGFR)

    3 years

  • The number of patients who have new or worsening diabetic neuropathy

    3 years

  • The number of patients who have new or worsening diabetic retinopathy

    3 years

  • changes in CIMT from baseline to the 3rd year

    18 months and 3 year

  • +4 more secondary outcomes

Study Arms (2)

colchicine

ACTIVE COMPARATOR

0.5mg/d colchicine

Drug: colchicine 0.5mg/d

placebo

PLACEBO COMPARATOR

appearance is same as colchicine

Drug: placebo 0.5mg/d

Interventions

colchicine 0.5mg/dDRUG

on the basis of standard therapy to manage hyperglycemia, hypertension,dislipidemia etc.

colchicine
placebo 0.5mg/dDRUG

on the basis of standard therapy to manage hyperglycemia, hypertension,dislipidemia etc.

placebo

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Well informed of the procedures of this trial and informed consent is obtained
  • Voluntarily accept standardized treatment
  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (9)

  • Nidorf SM, Eikelboom JW, Budgeon CA, Thompson PL. Low-dose colchicine for secondary prevention of cardiovascular disease. J Am Coll Cardiol. 2013 Jan 29;61(4):404-410. doi: 10.1016/j.jacc.2012.10.027. Epub 2012 Dec 19.

    PMID: 23265346BACKGROUND

  • Nidorf M, Thompson PL. Effect of colchicine (0.5 mg twice daily) on high-sensitivity C-reactive protein independent of aspirin and atorvastatin in patients with stable coronary artery disease. Am J Cardiol. 2007 Mar 15;99(6):805-7. doi: 10.1016/j.amjcard.2006.10.039. Epub 2007 Jan 16.

    PMID: 17350370BACKGROUND

  • Navarro-Gonzalez JF, Mora-Fernandez C, Muros de Fuentes M, Garcia-Perez J. Inflammatory molecules and pathways in the pathogenesis of diabetic nephropathy. Nat Rev Nephrol. 2011 Jun;7(6):327-40. doi: 10.1038/nrneph.2011.51. Epub 2011 May 3.

    PMID: 21537349BACKGROUND

  • Bots ML, Visseren FL, Evans GW, Riley WA, Revkin JH, Tegeler CH, Shear CL, Duggan WT, Vicari RM, Grobbee DE, Kastelein JJ; RADIANCE 2 Investigators. Torcetrapib and carotid intima-media thickness in mixed dyslipidaemia (RADIANCE 2 study): a randomised, double-blind trial. Lancet. 2007 Jul 14;370(9582):153-160. doi: 10.1016/S0140-6736(07)61088-5.

    PMID: 17630038BACKGROUND

  • de Zeeuw D, Agarwal R, Amdahl M, Audhya P, Coyne D, Garimella T, Parving HH, Pritchett Y, Remuzzi G, Ritz E, Andress D. Selective vitamin D receptor activation with paricalcitol for reduction of albuminuria in patients with type 2 diabetes (VITAL study): a randomised controlled trial. Lancet. 2010 Nov 6;376(9752):1543-51. doi: 10.1016/S0140-6736(10)61032-X.

    PMID: 21055801BACKGROUND

  • ADVANCE Collaborative Group; Patel A, MacMahon S, Chalmers J, Neal B, Billot L, Woodward M, Marre M, Cooper M, Glasziou P, Grobbee D, Hamet P, Harrap S, Heller S, Liu L, Mancia G, Mogensen CE, Pan C, Poulter N, Rodgers A, Williams B, Bompoint S, de Galan BE, Joshi R, Travert F. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2560-72. doi: 10.1056/NEJMoa0802987. Epub 2008 Jun 6.

    PMID: 18539916BACKGROUND

  • Gaede P, Vedel P, Parving HH, Pedersen O. Intensified multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: the Steno type 2 randomised study. Lancet. 1999 Feb 20;353(9153):617-22. doi: 10.1016/S0140-6736(98)07368-1.

    PMID: 10030326BACKGROUND

  • ORIGIN Trial Investigators; Gerstein HC, Bosch J, Dagenais GR, Diaz R, Jung H, Maggioni AP, Pogue J, Probstfield J, Ramachandran A, Riddle MC, Ryden LE, Yusuf S. Basal insulin and cardiovascular and other outcomes in dysglycemia. N Engl J Med. 2012 Jul 26;367(4):319-28. doi: 10.1056/NEJMoa1203858. Epub 2012 Jun 11.

    PMID: 22686416BACKGROUND

  • Li JJ, Lee SH, Kim DK, Jin R, Jung DS, Kwak SJ, Kim SH, Han SH, Lee JE, Moon SJ, Ryu DR, Yoo TH, Han DS, Kang SW. Colchicine attenuates inflammatory cell infiltration and extracellular matrix accumulation in diabetic nephropathy. Am J Physiol Renal Physiol. 2009 Jul;297(1):F200-9. doi: 10.1152/ajprenal.90649.2008. Epub 2009 Apr 15.

    PMID: 19369290BACKGROUND

MeSH Terms

Conditions

Diabetic NephropathiesDiabetes Mellitus, Type 2

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Qifu Li, PhD

    First Affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
director of the Endocrinology Department

Study Record Dates

First Submitted

January 4, 2014

First Posted

January 14, 2014

Study Start

December 1, 2013

Primary Completion

September 1, 2019

Study Completion

June 1, 2023

Last Updated

January 31, 2019

Record last verified: 2019-01

Locations

CN(1)