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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Metformin
Pioglitazone
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring YKL-40, Chronic low grade inflammation, type 2 diabetes mellitus, metformin, pioglitazone

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Metformin

Pioglitazone

Arm Description

patients receiving fixed dose metformin 1000 mg daily

patients receiving fixed dose pioglitazone 30 mg daily

Outcomes

Primary Outcome Measures

Serum concentration of YKL-40

Secondary Outcome Measures

Full Information

First Posted
October 13, 2013
Last Updated
October 15, 2013
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01963663
Brief Title
Metformin and Pioglitazone Effects on YKL-40 Concentrations in Type 2 Diabetes Patients
Official Title
Comparison of Metformin and Pioglitazone Effects on Serum YKL-40 Concentrations in Patients With Newly Diagnosed Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
YKL-40, Chronic low grade inflammation, type 2 diabetes mellitus, metformin, pioglitazone

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
patients receiving fixed dose metformin 1000 mg daily
Arm Title
Pioglitazone
Arm Type
Active Comparator
Arm Description
patients receiving fixed dose pioglitazone 30 mg daily
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
metformin 1000 mg daily in two divided doses of 500 mg tablets
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Intervention Description
pioglitazone 30 mg daily in two divided doses of 15 mg tablets
Primary Outcome Measure Information:
Title
Serum concentration of YKL-40
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alireza Esteghamati, M.D.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes Clinic, Vali-Asr Hospital, Tehran University of Medical Sciences
City
Tehran
ZIP/Postal Code
13145-784
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25607338
Citation
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.
Results Reference
derived

Learn more about this trial

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

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