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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Comparing Effects of Metformin and Pioglitazone on Regulation of Serum Adipokines in Newly Diagnosed Type 2 Diabetes Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593371
• Other study ID #: 90-D-130-655
• Status: Completed
• Phase: N/A
• First received: May 5, 2012
• Last updated: May 8, 2012
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: May 2012
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health and Medical Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: January 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Metformin
Metformin 1000 mg fixed dose, twice daily (500 mg tablets x 2)
• Pioglitazone
Pioglitazone 30 mg fixed dose, twice daily (15 mg tablets x 2)

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tehran University of Medical Sciences	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum concentrations of omentin	Serum concentrations of adipose tissue derived cytokine omentin	12 weeks	No
Primary	Serum concentrations of leptin	Serum concentrations of adipose tissue derived cytokine leptin	12 weeks	No