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

Overview

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.

Full Title of Study: “Comparison of Metformin and Pioglitazone Effects on Serum YKL-40 Concentrations in Patients With Newly Diagnosed Type 2 Diabetes”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2013

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

Arms, Groups and Cohorts

  • Active Comparator: Metformin
    • patients receiving fixed dose metformin 1000 mg daily
  • Active Comparator: Pioglitazone
    • patients receiving fixed dose pioglitazone 30 mg daily

Clinical Trial Outcome Measures

Primary Measures

  • Serum concentration of YKL-40
    • Time Frame: 12 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria for diagnosis of diabetes Exclusion Criteria:

  • positive history for taking anti-diabetes medications of any class in the past – positive current history for taking over-the-counter vitamin or anti-oxidant supplements – presence of clinically significant chronic illnesses of the heart, lungs, or kidneys.

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tehran University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alireza Esteghamati, Professor Alireza Esteghamati – Tehran University of Medical Sciences
  • Overall Official(s)
    • Alireza Esteghamati, M.D., Principal Investigator, Tehran University of Medical Sciences

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