Metformin and Pioglitazone Effects on Fetuin-A and Osteoprotegrin Concentrations in Type 2 Diabetes Patients

January 2, 2014 updated by: Alireza Esteghamati, Tehran University of Medical Sciences

Comparative Effects of Metformin and Pioglitazone on Fetuin-A and Osteoprotegerin Concentrations in Patients With Newly Diagnosed Diabetes: A Randomized Clinical Trial

Oral hypoglycemic agents, along with dietary modification and exercise encompass the mainstay of treatment in early stages of T2DM. Biguanides and thiazolidinediones are two major groups of hypoglycemic medications that while function via different pathways, mare both effective in short- and long-term glucose control. These medications diminish or delay long term micro- and macrovascular complications associated with T2DM although at different rates. Excessive insulin resistance accounts for a sustained increase in cardiovascular incidents in T2DM subjects. Given the shared pathway of insulin resistance/fetuin-A/OPG in atherosclerosis formation, it is conceivable that insulin sensitizing anti-diabetes medications are able to modify successive CAD risk via direct and indirect amelioration of insulin resistance/fetuin-A/OPG. The present study is therefore designed to investigate the effects of metformin and pioglitazone monotherapy on serum concentrations of fetuin-A and OPG in a group of Iranian adults with newly diagnosed T2DM.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 13145-784
        • Diabetes Clinic, Vali-Asr Hospital, Tehran University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria (2011) for diagnosis of diabetes

Exclusion Criteria:

Previous intake of oral hypoglycemic agents for treatment of diabetes or other hyperglycemia associated conditions Intake of glucocorticoids in the past one year Major illnesses of heart, lung, kidney, and liver.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Metformin
patients receiving fixed dose metformin 1000 mg daily
Drug: Metformin
Metformin 1000 mg fixed dose, twice daily (500 mg tablets x 2)
Active Comparator: Pioglitazone
patients receiving fixed dose pioglitazone 30 mg daily
Drug: Pioglitazone
Pioglitazone 30 mg fixed dose, twice daily (15 mg tablets x 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum concentrations of fetuin-A
Time Frame: 12 weeks
12 weeks
Serum concentrations of osteoprotegrin
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Principal Investigator: Alireza Esteghamati, M.D, Tehran University of Medical Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

March 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

January 2, 2014

First Submitted That Met QC Criteria

January 2, 2014

First Posted (Estimate)

January 3, 2014

Study Record Updates

Last Update Posted (Estimate)

January 3, 2014

Last Update Submitted That Met QC Criteria

January 2, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90-111-60037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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