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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01963663
Recruitment Status : Completed
First Posted : October 16, 2013
Last Update Posted : October 16, 2013
Information provided by (Responsible Party):
Alireza Esteghamati, Tehran University of Medical Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Metformin Drug: Pioglitazone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Comparison of Metformin and Pioglitazone Effects on Serum YKL-40 Concentrations in Patients With Newly Diagnosed Type 2 Diabetes
Study Start Date : November 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Metformin
patients receiving fixed dose metformin 1000 mg daily
Drug: Metformin
metformin 1000 mg daily in two divided doses of 500 mg tablets

Active Comparator: Pioglitazone
patients receiving fixed dose pioglitazone 30 mg daily
Drug: Pioglitazone
pioglitazone 30 mg daily in two divided doses of 15 mg tablets

Primary Outcome Measures :
  1. Serum concentration of YKL-40 [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01963663

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Iran, Islamic Republic of
Diabetes Clinic, Vali-Asr Hospital, Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of, 13145-784
Sponsors and Collaborators
Tehran University of Medical Sciences
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Principal Investigator: Alireza Esteghamati, M.D. Tehran University of Medical Sciences
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Alireza Esteghamati, Professor Alireza Esteghamati, Tehran University of Medical Sciences Identifier: NCT01963663    
Other Study ID Numbers: 92/d/130/499
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013
Keywords provided by Alireza Esteghamati, Tehran University of Medical Sciences:
Chronic low grade inflammation
type 2 diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs