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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01521624
Enrollment
108
Registered
2012-01-30
Start date
2010-10-31
Completion date
2011-09-30
Last updated
2012-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

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.

Interventions

DRUGMetformin

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

Sponsors

Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Serum concentrations of various markers of oxidative stress12 weeksSerum 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.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026