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

T

Tehran University of Medical Sciences

Status

Completed

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Pioglitazone
Drug: Metformin

Study type

Interventional

Funder types

Other

Identifiers

NCT01963663
92/d/130/499

Details and patient eligibility

About

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.

Enrollment

84 patients

Sex

All

Ages

35+ years old

Volunteers

No 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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

84 participants in 2 patient groups

Metformin
Active Comparator group
Description:
patients receiving fixed dose metformin 1000 mg daily
Treatment:
Drug: Metformin
Pioglitazone
Active Comparator group
Description:
patients receiving fixed dose pioglitazone 30 mg daily
Treatment:
Drug: Pioglitazone

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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