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

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ClinicalTrials.gov Identifier: NCT01521624
Recruitment Status : Completed
First Posted : January 30, 2012
Last Update Posted : January 31, 2012
Information provided by (Responsible Party):
Alireza Esteghamati, Tehran University of Medical Sciences

Brief Summary:
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.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Drug: Metformin

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : October 2010
Primary Completion Date : March 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01521624

Iran, Islamic Republic of
Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of, 13145-784
Sponsors and Collaborators
Tehran University of Medical Sciences
Principal Investigator: Alireza Esteghamati, M.D. Tehran University of Medical Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alireza Esteghamati, Professor Alireza Esteghamati, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01521624     History of Changes
Other Study ID Numbers: 90-01-30-13350
First Posted: January 30, 2012    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs