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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963663
• Other study ID #: 92/d/130/499
• Status: Completed
• Phase: N/A
• First received: October 13, 2013
• Last updated: October 15, 2013
• Start date: November 2012
• Est. completion date: April 2013

Study information

• Verified date: October 2013
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Metformin
metformin 1000 mg daily in two divided doses of 500 mg tablets
• Pioglitazone
pioglitazone 30 mg daily in two divided doses of 15 mg tablets

Locations

Country	Name	City	State
Iran, Islamic Republic of	Diabetes Clinic, Vali-Asr Hospital, Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum concentration of YKL-40		12 weeks	No