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OpenTrials
Completed

NCT Number: NCT01963663

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

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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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes Clinic, Vali-Asr Hospital, Tehran University of Medical Sciences

Tehran, Tehran Province, 13145-784, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

metformin

Drug

metformin 1000 mg daily in two divided doses of 500 mg tablets

pioglitazone

Drug

pioglitazone 30 mg daily in two divided doses of 15 mg tablets

Primary outcomes

  1. Serum concentration of YKL-40

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

Comparison of Metformin and Pioglitazone Effects on Serum YKL-40 Concentrations in Patients With Newly Diagnosed Type 2 Diabetes

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 16, 2013
Registry last updated
Oct 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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