Metformin Effects on Oxidative Stress Parameters in Newly Diagnosed Type 2 Diabetes Patients

January 28, 2012 updated by: Alireza Esteghamati, Tehran University of Medical Sciences

Comparing Effects of Metformin Plus Life Style Modification Compared With Life Style Modification Alone in Lowering Parameters of Oxidative Stress in Newly Diagnosed Type 2 Diabetes Patients

Oxidative stress plays a key role in the pathogenesis of diabetes complications. Chronic hyperglycemia and disturbed lipid regulation commonly seen in diabetes are the main causes of this process. Despite the critical role of oxidative stress in diabetes, most clinical trials with available antioxidants and vitamins have either failed to show any long term benefits or have produced inconsistent results (10-11). There has been growing interest in establishing the possible roles of oral hypoglycemic agents including Metformin in reduction of oxidative stress. Metformin, the most common prescribed oral medication in type 2 diabetes, lowers HbA1c around 1.5%, rarely causes hypoglycemia (compared with insulin or sulfonylureas), has relatively few contraindications, its adverse effects are generally tolerable, does not cause weight gain, is cheap, and is highly acceptable among patients. Given the long term benefits observed with metformin use, a role in modulating oxidative stress is imputable. We designed this study to evaluate the actions of metformin on oxidative stress in a group of medication-naïve newly diagnosed type 2 diabetes patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

108

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 for diagnosis of diabetes

Exclusion Criteria:

  • No history of serious chronic illnesses of heart, lung, and kidney
  • No prior treatment with anti-diabetes medications for either diabetes or conditions associated with hyperglycemia
  • No intake of prescribed or over-the-counter vitamins C and E in the past year; - No intake of aspirin in the past year
  • No history of excessive alcohol intake in the past year

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: Case
Metformin 1000 mg Daily in two divided doses plus advice for lifestyle modification
Drug: Metformin
Metformin 1000 mg Daily in two divided doses plus advice for lifestyle modification
No Intervention: Control
Subjects provided only advice for lifestyle modification with no drug intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum concentrations of various markers of oxidative stress
Time Frame: 12 weeks
Serum concentrations of markers of oxidative stress (i.e. advanced glycation end products, advanced oxidation protein products, ferritin reducing ability of plasma) along with activities of antioxidant enzymes (i.e. paraoxonase1, lecithin cholesterol asyltransferase) are measured. To assess the change in inflammatory condition associated with fat tissue dysfunction (a close entity to oxidative stress) serum concentrations of fat tissue hormones (i.e. leptin, vaspin, adiponectin, visfatin)are also assessed.
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

October 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

January 26, 2012

First Submitted That Met QC Criteria

January 27, 2012

First Posted (Estimate)

January 30, 2012

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 28, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 90-01-30-13350

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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