search
Back to results

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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Metformin
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 2 Diabetes Mellitus

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tehran University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Case

Control

Arm Description

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

Subjects provided only advice for lifestyle modification with no drug intervention

Outcomes

Primary Outcome Measures

Serum concentrations of various markers of oxidative stress
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.

Secondary Outcome Measures

Full Information

First Posted
January 26, 2012
Last Updated
January 28, 2012
Sponsor
Tehran University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT01521624
Brief Title
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

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Case
Arm Type
Active Comparator
Arm Description
Metformin 1000 mg Daily in two divided doses plus advice for lifestyle modification
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects provided only advice for lifestyle modification with no drug intervention
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin 1000 mg Daily in two divided doses plus advice for lifestyle modification
Primary Outcome Measure Information:
Title
Serum concentrations of various markers of oxidative stress
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alireza Esteghamati, M.D.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehran University of Medical Sciences
City
Tehran
ZIP/Postal Code
13145-784
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
25138574
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.
Results Reference
derived
PubMed Identifier
23891275
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.
Results Reference
derived
PubMed Identifier
22963881
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs