Comparison of Metformin and Pioglitazone Effects on Adipokines Concentrations in Newly Diagnosed Type 2 Diabetes Patients

NCT ID: NCT01593371

Last Updated: 2012-05-09

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

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-01-31

Brief Summary

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Oral hypoglycemic agents encompass the mainstay of treatment in the majority of patients with type 2 diabetes. Thiazolidinediones (such a pioglitazone) and Biguanides (such as metformin), are two major groups of hypoglycemic medications that while function via different pathways, are both effective in short- and long-term glycemic control . These medications diminish or at least delay long term micro- and macrovascular complications associated with prolonged insulin resistance although at different rates. The mechanisms by which this aim is achieved, nevertheless, remains largely unclear. With adipokines playing a key role in development of both insulin resistance and atherosclerosis, oral hypoglycemic agents might regulate these substances by direct and indirect routes.

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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Metformin

patients receiving fixed dose metformin 1000 mg daily

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Metformin 1000 mg fixed dose, twice daily (500 mg tablets x 2)

Pioglitazone

patients receiving fixed dose pioglitazone 30 mg daily

Group Type ACTIVE_COMPARATOR

Pioglitazone

Intervention Type DRUG

Pioglitazone 30 mg fixed dose, twice daily (15 mg tablets x 2)

Interventions

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Metformin

Metformin 1000 mg fixed dose, twice daily (500 mg tablets x 2)

Intervention Type DRUG

Pioglitazone

Pioglitazone 30 mg fixed dose, twice daily (15 mg tablets x 2)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria (2011) for diagnosis of diabetes

Exclusion Criteria

* previous intake of oral hypoglycemic agents for treatment of diabetes or other hyperglycemia associated conditions
* intake of glucocorticoids in the past one year
* major illnesses of heart, lung, kidney, and liver.
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, Ghasemiesfe M, Mousavizadeh M, Noshad S, Nakhjavani M. Pioglitazone and metformin are equally effective in reduction of chemerin in patients with type 2 diabetes. J Diabetes Investig. 2014 May 4;5(3):327-32. doi: 10.1111/jdi.12157. Epub 2013 Oct 22.

Reference Type DERIVED
PMID: 24843782 (View on PubMed)

Other Identifiers

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90-D-130-655

Identifier Type: -

Identifier Source: org_study_id

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