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

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

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Purpose	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	Type 2 Diabetes Mellitus
Intervention	Drug: Metformin
Phase	N/A
Sponsor	Tehran University of Medical Sciences
Responsible Party	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier	NCT01521624
First Received	January 26, 2012
Last Updated	January 28, 2012
Last verified	January 2012

Tracking Information[ + expand ][ + ]

First Received Date	January 26, 2012
Last Updated Date	January 28, 2012
Start Date	October 2010
Estimated Primary Completion Date	September 2011
Current Primary Outcome Measures	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.
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Metformin Effects on Oxidative Stress Parameters in Newly Diagnosed Type 2 Diabetes Patients
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
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Metformin Metformin 1000 mg Daily in two divided doses plus advice for lifestyle modification
Study Arm (s)	Active Comparator: Case 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

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	108
Estimated Completion Date	September 2011
Estimated Primary Completion Date	March 2011
Eligibility Criteria	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
Gender	Both
Ages	40 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Iran, Islamic Republic of

Administrative Information[ + expand ][ + ]

NCT Number	NCT01521624
Other Study ID Numbers	90-01-30-13350
Has Data Monitoring Committee	No
Information Provided By	Tehran University of Medical Sciences
Study Sponsor	Tehran University of Medical Sciences
Collaborators	Not Provided
Investigators	Principal Investigator: Alireza Esteghamati, M.D. Tehran University of Medical Sciences
Verification Date	January 2012

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