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 | Intervention |
|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Metformin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| 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 |
- 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.
| Enrollment: | 108 |
| Study Start Date: | October 2010 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Case
Metformin 1000 mg Daily in two divided doses plus advice for lifestyle modification
|
Drug: Metformin
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
|
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Iran, Islamic Republic of | |
| Tehran University of Medical Sciences | |
| Tehran, Iran, Islamic Republic of, 13145-784 | |
| Principal Investigator: | Alireza Esteghamati, M.D. | Tehran University of Medical Sciences |
More Information
No publications provided by Tehran University of Medical Sciences
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alireza Esteghamati, Professor Alireza Esteghamati, Tehran University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01521624 History of Changes |
| Other Study ID Numbers: | 90-01-30-13350 |
| Study First Received: | January 26, 2012 |
| Last Updated: | January 28, 2012 |
| Health Authority: | Iran: Ministry of Health |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013