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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014