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

• ClinicalTrials.gov Identifier: NCT01521624
• Recruitment Status: Completed
• First Posted: January 30, 2012
• Last Update Posted: January 31, 2012
• Sponsor: Tehran University of Medical Sciences
• Information provided by (Responsible Party): Alireza Esteghamati, Tehran University of Medical Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: Metformin	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: October 2010
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: September 2011

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Serum concentrations of various markers of oxidative stress [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Iran, Islamic Republic of

Tehran University of Medical Sciences

Tehran, Iran, Islamic Republic of, 13145-784

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

• Principal Investigator: Alireza Esteghamati, M.D.; Tehran University of Medical Sciences

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Esteghamati A, Rezvani S, Khajeh E, Ebadi M, Nakhjavani M, Noshad S. Comparative effects of metformin and pioglitazone on YKL-40 in type 2 diabetes: a randomized clinical trial. J Endocrinol Invest. 2014 Dec;37(12):1211-8. doi: 10.1007/s40618-014-0154-x. Epub 2014 Aug 20.

Mirmiranpour H, Mousavizadeh M, Noshad S, Ghavami M, Ebadi M, Ghasemiesfe M, Nakhjavani M, Esteghamati A. Comparative effects of pioglitazone and metformin on oxidative stress markers in newly diagnosed type 2 diabetes patients: a randomized clinical trial. J Diabetes Complications. 2013 Sep-Oct;27(5):501-7. doi: 10.1016/j.jdiacomp.2013.05.006. Epub 2013 Jul 23.

Esteghamati A, Eskandari D, Mirmiranpour H, Noshad S, Mousavizadeh M, Hedayati M, Nakhjavani M. Effects of metformin on markers of oxidative stress and antioxidant reserve in patients with newly diagnosed type 2 diabetes: a randomized clinical trial. Clin Nutr. 2013 Apr;32(2):179-85. doi: 10.1016/j.clnu.2012.08.006. Epub 2012 Aug 21.

• 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
• First Posted: January 30, 2012
• Last Update Posted: January 31, 2012
• Last Verified: January 2012

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