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

NCT01593371 | Completed

• 1 other identifier: 90-D-130-655
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Adipokines; leptin; chemerin; omentin; metformin; type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (2)

• Serum concentrations of omentin

  Serum concentrations of adipose tissue derived cytokine omentin

  12 weeks

• Serum concentrations of leptin

  Serum concentrations of adipose tissue derived cytokine leptin

  12 weeks

Study Arms (2)

Metformin

ACTIVE COMPARATOR

patients receiving fixed dose metformin 1000 mg daily

Drug: Metformin

Pioglitazone

ACTIVE COMPARATOR

patients receiving fixed dose pioglitazone 30 mg daily

Drug: Pioglitazone

Interventions

Metformin DRUG

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

Metformin

Pioglitazone DRUG

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

Pioglitazone

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Tehran University of Medical Sciences

Tehran, Tehran Province, 13145-784, Iran

Location

Related Publications (1)

• 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.

  PMID: 24843782 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Metformin; Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Thiazolidinediones; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Alireza Esteghamati, M.D.

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Alireza Esteghamati

Study Record Dates

• First Submitted: May 5, 2012
• First Posted: May 8, 2012
• Study Start: July 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: January 1, 2012
• Last Updated: May 9, 2012

Record last verified: 2012-05

Locations

IR (1)