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

NCT ID: NCT01963663

Last Updated: 2013-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-04-30

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Metformin

patients receiving fixed dose metformin 1000 mg daily

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

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

Pioglitazone

patients receiving fixed dose pioglitazone 30 mg daily

Group Type ACTIVE_COMPARATOR

Pioglitazone

Intervention Type DRUG

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

Interventions

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Metformin

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

Intervention Type DRUG

Pioglitazone

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Alireza Esteghamati

Professor Alireza Esteghamati

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alireza Esteghamati, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

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

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

References

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Esteghamati A, Azizi R, Ebadi M, Noshad S, Mousavizadeh M, Afarideh M, Nakhjavani M. The comparative effect of pioglitazone and metformin on serum osteoprotegerin, adiponectin and intercellular adhesion molecule concentrations in patients with newly diagnosed type 2 diabetes: a randomized clinical trial. Exp Clin Endocrinol Diabetes. 2015 May;123(5):289-95. doi: 10.1055/s-0034-1396864. Epub 2015 Jan 21.

Reference Type DERIVED
PMID: 25607338 (View on PubMed)

Other Identifiers

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92/d/130/499

Identifier Type: -

Identifier Source: org_study_id