Clinical trial NCT01521624: Metformin Effects on Oxidative Stress Parameters in Newly Diagnosed Type 2 Diabetes Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-01-30
Enrollment: 108
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Serum concentrations of various markers of oxidative stress
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences
Study officials:
affiliation: Tehran University of Medical Sciences
name: Alireza Esteghamati, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.