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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Metformin

• Registration Number: NCT01521624
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-03
• Study Completion: 2011-09
• Status Verified: 2012-01
• Study First Submitted: 2012-01-26
• Study First Submitted QC: 2012-01-27
• Last Update Submitted: 2012-01-28
• Study First Posted: 2012-01-30
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Case	Metformin	Metformin 1000 mg Daily in two divided doses plus advice for lifestyle modification

Primary Outcome Measures

Name	Time	Method
Serum concentrations of various markers of oxidative stress	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.

Trial Locations

Locations (1)

Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of