Low-dose Colchicine in Patients With Type 2 Diabetes Mellitus and Microalbuminuria
NCT ID: NCT02035891
Last Updated: 2019-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
160 participants
INTERVENTIONAL
2013-12-31
2023-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of the Protective Effect of Low-dose Aspirin on Renal Function in Patients With Early Diabetic Nephropathy
NCT06068439
Effects of SGLT2 Inhibition Treatment on Different Levels of Albuminuria in Patients With Type 2 Diabetes
NCT04127084
Study of CS-3150 in Hypertensive Patients With Type 2 Diabetes and Albuminuria
NCT02807974
Effect of Novel Antidiabetic Drug Combined With Angiotensin Receptor/Neprilysin Inhibitor on Urinary Protein
NCT05922852
A Study to Evaluate the Effect of CCX140-B on Urinary Albumin Excretion in Subjects With Type 2 Diabetes and Albuminuria
NCT01440257
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
colchicine
0.5mg/d colchicine
colchicine 0.5mg/d
on the basis of standard therapy to manage hyperglycemia, hypertension,dislipidemia etc.
placebo
appearance is same as colchicine
placebo 0.5mg/d
on the basis of standard therapy to manage hyperglycemia, hypertension,dislipidemia etc.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
colchicine 0.5mg/d
on the basis of standard therapy to manage hyperglycemia, hypertension,dislipidemia etc.
placebo 0.5mg/d
on the basis of standard therapy to manage hyperglycemia, hypertension,dislipidemia etc.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
30 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chongqing Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Qifu Li
director of the Endocrinology Department
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Qifu Li, PhD
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital of Chongqing Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CQMU-2013-QLi
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.