drugset / Trial / NCT01963663

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

NCT01963663

RandomizedParallel-groupOpen-labelBasic science

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.

Timeline

Start
2012-11
Primary completion
2013-03
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metformin Small molecule 1000 mg
Comparator Pioglitazone Small molecule 30 mg