Comparison of Metformin and Pioglitazone Effects on Adipokines Concentrations in Newly Diagnosed Type 2 Diabetes Patients
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| First Received Date ICMJE | May 5, 2012 | ||||
| Last Updated Date | May 8, 2012 | ||||
| Start Date ICMJE | July 2011 | ||||
| Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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. |
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| Change History | Complete list of historical versions of study NCT01593371 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Comparison of Metformin and Pioglitazone Effects on Adipokines Concentrations in Newly Diagnosed Type 2 Diabetes Patients | ||||
| Official Title ICMJE | Comparing Effects of Metformin and Pioglitazone on Regulation of Serum Adipokines in Newly Diagnosed Type 2 Diabetes Patients | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
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| Condition ICMJE | Type 2 Diabetes Mellitus | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 98 | ||||
| Completion Date | January 2012 | ||||
| Primary Completion Date | October 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 40 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Iran, Islamic Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01593371 | ||||
| Other Study ID Numbers ICMJE | 90-D-130-655 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Alireza Esteghamati, Tehran University of Medical Sciences | ||||
| Study Sponsor ICMJE | Tehran University of Medical Sciences | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Tehran University of Medical Sciences | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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