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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alireza Esteghamati, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01593371
First received: May 5, 2012
Last updated: May 8, 2012
Last verified: May 2012

May 5, 2012
May 8, 2012
July 2011
October 2011   (final data collection date for primary outcome measure)
  • Serum concentrations of omentin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Serum concentrations of adipose tissue derived cytokine omentin
  • Serum concentrations of leptin [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Serum concentrations of adipose tissue derived cytokine leptin
Serum concentrations of various adipokines [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Serum concentrations of adipose tissue derived cytokines (adipokines) including but not limited to adiponectin, leptin, omentin, chemerin, vaspin, and visfatin are determined at baseline and after 12 weeks.
Complete list of historical versions of study NCT01593371 on ClinicalTrials.gov Archive Site
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Comparison of Metformin and Pioglitazone Effects on Adipokines Concentrations in Newly Diagnosed Type 2 Diabetes Patients
Comparing Effects of Metformin and Pioglitazone on Regulation of Serum Adipokines in Newly Diagnosed Type 2 Diabetes Patients

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Type 2 Diabetes Mellitus
  • Drug: Metformin
    Metformin 1000 mg fixed dose, twice daily (500 mg tablets x 2)
  • Drug: Pioglitazone
    Pioglitazone 30 mg fixed dose, twice daily (15 mg tablets x 2)
  • Active Comparator: Metformin
    patients receiving fixed dose metformin 1000 mg daily
    Intervention: Drug: Metformin
  • Active Comparator: Pioglitazone
    patients receiving fixed dose pioglitazone 30 mg daily
    Intervention: Drug: Pioglitazone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
98
January 2012
October 2011   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01593371
90-D-130-655
No
Alireza Esteghamati, Tehran University of Medical Sciences
Tehran University of Medical Sciences
Not Provided
Principal Investigator: Alireza Esteghamati, M.D. Tehran University of Medical Sciences
Tehran University of Medical Sciences
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP