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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
History of Changes
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
 Drug: Metformin
Drug: Pioglitazone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Comparing Effects of Metformin and Pioglitazone on Regulation of Serum Adipokines in Newly Diagnosed Type 2 Diabetes Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • 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


Enrollment: 98
Study Start Date: July 2011
Study Completion Date: January 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin
patients receiving fixed dose metformin 1000 mg daily
 Drug: Metformin
Metformin 1000 mg fixed dose, twice daily (500 mg tablets x 2)
Active Comparator: Pioglitazone
patients receiving fixed dose pioglitazone 30 mg daily
 Drug: Pioglitazone
Pioglitazone 30 mg fixed dose, twice daily (15 mg tablets x 2)

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01593371

Locations
Iran, Islamic Republic of
Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of, 13145-784
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Principal Investigator: Alireza Esteghamati, M.D. Tehran University of Medical Sciences
  More Information

No publications provided

Responsible Party: Alireza Esteghamati, Professor Alireza Esteghamati, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01593371     History of Changes
Other Study ID Numbers: 90-D-130-655
Study First Received: May 5, 2012
Last Updated: May 8, 2012
Health Authority: Iran: Ministry of Health and Medical Education

Keywords provided by Tehran University of Medical Sciences:
Adipokines
leptin
chemerin
 omentin
metformin
type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Pioglitazone
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013