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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Metformin; Drug: Pioglitazone

• Registration Number: NCT01963663
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Primary Completion: 2013-03
• Study Completion: 2013-04
• Status Verified: 2013-10
• Study First Submitted: 2013-10-13
• Study First Submitted QC: 2013-10-15
• Last Update Submitted: 2013-10-15
• Study First Posted: 2013-10-16
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	patients receiving fixed dose metformin 1000 mg daily
Pioglitazone	Pioglitazone	patients receiving fixed dose pioglitazone 30 mg daily

Primary Outcome Measures

Name	Time	Method
Serum concentration of YKL-40	12 weeks

Trial Locations

Locations (1)

Diabetes Clinic, Vali-Asr Hospital, Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of