Comparison of Metformin and Pioglitazone Effects on Adipokines Concentrations in Newly Diagnosed Type 2 Diabetes Patients

May 8, 2012 updated by: Alireza Esteghamati, Tehran University of Medical Sciences

Comparing Effects of Metformin and Pioglitazone on Regulation of Serum Adipokines in Newly Diagnosed Type 2 Diabetes Patients

Oral hypoglycemic agents encompass the mainstay of treatment in the majority of patients with type 2 diabetes. Thiazolidinediones (such a pioglitazone) and Biguanides (such as metformin), are two major groups of hypoglycemic medications that while function via different pathways, are both effective in short- and long-term glycemic control . These medications diminish or at least delay long term micro- and macrovascular complications associated with prolonged insulin resistance although at different rates. The mechanisms by which this aim is achieved, nevertheless, remains largely unclear. With adipokines playing a key role in development of both insulin resistance and atherosclerosis, oral hypoglycemic agents might regulate these substances by direct and indirect routes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

98

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

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

40 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
Measure Description
Time Frame
Serum concentrations of omentin
Time Frame: 12 weeks
Serum concentrations of adipose tissue derived cytokine omentin
12 weeks
Serum concentrations of leptin
Time Frame: 12 weeks
Serum concentrations of adipose tissue derived cytokine leptin
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

July 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

May 5, 2012

First Submitted That Met QC Criteria

May 7, 2012

First Posted (Estimate)

May 8, 2012

Study Record Updates

Last Update Posted (Estimate)

May 9, 2012

Last Update Submitted That Met QC Criteria

May 8, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90-D-130-655

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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