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

NCT ID: NCT01521624

Last Updated: 2012-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Case

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

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

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

Control

Subjects provided only advice for lifestyle modification with no drug intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Metformin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Alireza Esteghamati

Professor Alireza Esteghamati

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alireza Esteghamati, M.D.

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

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Tehran University of Medical Sciences

Tehran, Tehran Province, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 25138574 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23891275 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22963881 (View on PubMed)

Other Identifiers

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90-01-30-13350

Identifier Type: -

Identifier Source: org_study_id