MedTrace Logo

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

NCT02035891 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2019-01-31

No results posted yet for this study

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.

Conditions

  • Diabetic Nephropathy

Interventions

DRUG

colchicine 0.5mg/d

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

DRUG

placebo 0.5mg/d

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

Sponsors & Collaborators

  • Chongqing Medical University

    lead OTHER

Principal Investigators

  • Qifu Li, PhD · First Affiliated Hospital of Chongqing Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2019-09-30
Completion
2023-06-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02035891 on ClinicalTrials.gov