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Metformin and Pioglitazone Effects on YKL-40 Concentrations in Type 2 Diabetes Patients

NCT01963663 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2013-10-16

No results posted yet for this study

Summary

Patients with type 2 diabetes are at an increased risk for developing atherosclerosis, largely due to the underlying insulin resistance and chronic low grade inflammation. Cardiovascular events could be prevented with proper interventions targeted at ameliorating the aforementioned detrimental processes. YKL-40, a novel surrogate marker of acute and chronic inflammatory states has been implicated to have a putative role in both pathways. Given the shared pathway of insulin resistance and atherosclerosis, it is conceivable that anti-diabetes medications are able to modify coronary artery disease risk via direct and indirect amelioration of YKL-40 concentrations. The present clinical trial was therefore launched to examine the comparative effects of metformin and pioglitazone, two commonly prescribed anti-diabetes medications on YKL-40 concentrations in medication-naïve, newly-diagnosed type 2 diabetes patients.

Conditions

Interventions

DRUG

Metformin

metformin 1000 mg daily in two divided doses of 500 mg tablets

DRUG

Pioglitazone

pioglitazone 30 mg daily in two divided doses of 15 mg tablets

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Alireza Esteghamati, M.D. · Tehran University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2013-03-31
Completion
2013-04-30

Countries

  • Iran

Study Locations

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Entities

Drugs
Diseases

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 NCT01963663 on ClinicalTrials.gov