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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alireza Esteghamati, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01521624
First received: January 26, 2012
Last updated: January 28, 2012
Last verified: January 2012

January 26, 2012
January 28, 2012
October 2010
March 2011   (final data collection date for primary outcome measure)
Serum concentrations of various markers of oxidative stress [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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.
Completion of three months treatment [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Completion of three months treatment with Metformin
Complete list of historical versions of study NCT01521624 on ClinicalTrials.gov Archive Site
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Metformin Effects on Oxidative Stress Parameters in Newly Diagnosed Type 2 Diabetes Patients
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
Drug: Metformin
Metformin 1000 mg Daily in two divided doses plus advice for lifestyle modification
  • Active Comparator: Case
    Metformin 1000 mg Daily in two divided doses plus advice for lifestyle modification
    Intervention: Drug: Metformin
  • No Intervention: Control
    Subjects provided only advice for lifestyle modification with no drug intervention

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
108
September 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01521624
90-01-30-13350
No
Alireza Esteghamati, Tehran University of Medical Sciences
Tehran University of Medical Sciences
Not Provided
Principal Investigator: Alireza Esteghamati, M.D. Tehran University of Medical Sciences
Tehran University of Medical Sciences
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP