Back to resultsMetformin and Pioglitazone Effects on Fetuin-A and Osteoprotegrin Concentrations in 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 Fetuin-A, OPG, Metformin, Pioglitazone
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
- Diabetes Clinic, Vali-Asr Hospital, 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 fetuin-A
Serum concentrations of osteoprotegrin
Secondary Outcome Measures
Full Information
NCT ID
NCT02027103
First Posted
January 2, 2014
Last Updated
January 2, 2014
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02027103
Brief Title
Metformin and Pioglitazone Effects on Fetuin-A and Osteoprotegrin Concentrations in Type 2 Diabetes Patients
Official Title
Comparative Effects of Metformin and Pioglitazone on Fetuin-A and Osteoprotegerin Concentrations in Patients With Newly Diagnosed Diabetes: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
April 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, along with dietary modification and exercise encompass the mainstay of treatment in early stages of T2DM. Biguanides and thiazolidinediones are two major groups of hypoglycemic medications that while function via different pathways, mare both effective in short- and long-term glucose control. These medications diminish or delay long term micro- and macrovascular complications associated with T2DM although at different rates. Excessive insulin resistance accounts for a sustained increase in cardiovascular incidents in T2DM subjects. Given the shared pathway of insulin resistance/fetuin-A/OPG in atherosclerosis formation, it is conceivable that insulin sensitizing anti-diabetes medications are able to modify successive CAD risk via direct and indirect amelioration of insulin resistance/fetuin-A/OPG. The present study is therefore designed to investigate the effects of metformin and pioglitazone monotherapy on serum concentrations of fetuin-A and OPG in a group of Iranian adults with newly diagnosed T2DM.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Fetuin-A, OPG, Metformin, Pioglitazone
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
102 (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 fetuin-A
Time Frame
12 weeks
Title
Serum concentrations of osteoprotegrin
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 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
Diabetes Clinic, Vali-Asr Hospital, Tehran University of Medical Sciences
City
Tehran
ZIP/Postal Code
13145-784
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
25450818
Citation
Esteghamati A, Afarideh M, Feyzi S, Noshad S, Nakhjavani M. Comparative effects of metformin and pioglitazone on fetuin-A and osteoprotegerin concentrations in patients with newly diagnosed diabetes: A randomized clinical trial. Diabetes Metab Syndr. 2015 Oct-Dec;9(4):258-65. doi: 10.1016/j.dsx.2014.09.009. Epub 2014 Oct 14.
Results Reference
derived
Learn more about this trial
Metformin and Pioglitazone Effects on Fetuin-A and Osteoprotegrin Concentrations in Type 2 Diabetes Patients
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