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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01963663

Enrollment

Registered

2013-10-16

Start date

2012-11-30

Completion date

2013-04-30

Last updated

2013-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

YKL-40, Chronic low grade inflammation, type 2 diabetes mellitus, metformin, pioglitazone

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.

Interventions

DRUGMetformin

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

DRUGPioglitazone

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Serum concentration of YKL-40	12 weeks

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026