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

Tehran University of Medical Sciences

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT01521624

90-01-30-13350

Details and patient eligibility

About

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.

Enrollment: 108 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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108 participants in 2 patient groups

Case

Active Comparator group

Description:

Metformin 1000 mg Daily in two divided doses plus advice for lifestyle modification

Treatment:

Drug: Metformin

Control

No Intervention group

Description:

Subjects provided only advice for lifestyle modification with no drug intervention