Back to resultsComparison of Metformin and Pioglitazone Effects on Adipokines Concentrations in Newly Diagnosed Type 2 Diabetes Patients
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Metformin
Pioglitazone
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Adipokines, leptin, chemerin, omentin, metformin, type 2 diabetes mellitus
Eligibility 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.
Sites / Locations
- Tehran University of Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Metformin
Pioglitazone
Arm Description
patients receiving fixed dose metformin 1000 mg daily
patients receiving fixed dose pioglitazone 30 mg daily
Outcomes
Primary Outcome Measures
Serum concentrations of omentin
Serum concentrations of adipose tissue derived cytokine omentin
Serum concentrations of leptin
Serum concentrations of adipose tissue derived cytokine leptin
Secondary Outcome Measures
Full Information
NCT ID
NCT01593371
First Posted
May 5, 2012
Last Updated
May 8, 2012
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01593371
Brief Title
Comparison of Metformin and Pioglitazone Effects on Adipokines Concentrations in Newly Diagnosed Type 2 Diabetes Patients
Official Title
Comparing Effects of Metformin and Pioglitazone on Regulation of Serum Adipokines in Newly Diagnosed Type 2 Diabetes Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Adipokines, leptin, chemerin, omentin, metformin, type 2 diabetes mellitus
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
patients receiving fixed dose metformin 1000 mg daily
Arm Title
Pioglitazone
Arm Type
Active Comparator
Arm Description
patients receiving fixed dose pioglitazone 30 mg daily
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin 1000 mg fixed dose, twice daily (500 mg tablets x 2)
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Intervention Description
Pioglitazone 30 mg fixed dose, twice daily (15 mg tablets x 2)
Primary Outcome Measure Information:
Title
Serum concentrations of omentin
Description
Serum concentrations of adipose tissue derived cytokine omentin
Time Frame
12 weeks
Title
Serum concentrations of leptin
Description
Serum concentrations of adipose tissue derived cytokine leptin
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alireza Esteghamati, M.D.
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tehran University of Medical Sciences
City
Tehran
ZIP/Postal Code
13145-784
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24843782
Citation
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.
Results Reference
derived
Learn more about this trial
Comparison of Metformin and Pioglitazone Effects on Adipokines Concentrations in Newly Diagnosed Type 2 Diabetes Patients
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