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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alireza Esteghamati, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01963663
First received: October 13, 2013
Last updated: October 15, 2013
Last verified: October 2013

October 13, 2013
October 15, 2013
November 2012
March 2013   (final data collection date for primary outcome measure)
Serum concentration of YKL-40 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01963663 on ClinicalTrials.gov Archive Site
Not Provided
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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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
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.
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01963663
92/d/130/499
No
Alireza Esteghamati, Tehran University of Medical Sciences
Tehran University of Medical Sciences
Not Provided
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