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

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ClinicalTrials.gov Identifier: NCT01963663
Recruitment Status : Completed
First Posted : October 16, 2013
Last Update Posted : October 16, 2013
Information provided by (Responsible Party):

October 13, 2013
October 16, 2013
October 16, 2013
November 2012
March 2013   (Final data collection date for primary outcome measure)
Serum concentration of YKL-40 [ Time Frame: 12 weeks ]
Same as current
No Changes Posted
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Metformin and Pioglitazone Effects on YKL-40 Concentrations in Type 2 Diabetes Patients
Comparison of Metformin and Pioglitazone Effects on Serum YKL-40 Concentrations in Patients With Newly Diagnosed Type 2 Diabetes
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.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • 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
  • Active Comparator: Metformin
    patients receiving fixed dose metformin 1000 mg daily
    Intervention: Drug: Metformin
  • Active Comparator: Pioglitazone
    patients receiving fixed dose pioglitazone 30 mg daily
    Intervention: Drug: Pioglitazone
Esteghamati A, Azizi R, Ebadi M, Noshad S, Mousavizadeh M, Afarideh M, Nakhjavani M. The comparative effect of pioglitazone and metformin on serum osteoprotegerin, adiponectin and intercellular adhesion molecule concentrations in patients with newly diagnosed type 2 diabetes: a randomized clinical trial. Exp Clin Endocrinol Diabetes. 2015 May;123(5):289-95. doi: 10.1055/s-0034-1396864. Epub 2015 Jan 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
April 2013
March 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
35 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
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Alireza Esteghamati, Tehran University of Medical Sciences
Tehran University of Medical Sciences
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Principal Investigator: Alireza Esteghamati, M.D. Tehran University of Medical Sciences
Tehran University of Medical Sciences
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP