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CompletedNCT02027103Updated Jan 3, 2014

Metformin and Pioglitazone Effects on Fetuin-A and Osteoprotegrin Concentrations in Type 2 Diabetes Patients

An interventional study of Metformin and Pioglitazone in Type 2 Diabetes Mellitus, sponsored by Tehran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2014-01-03.

Sponsored by Tehran University of Medical Sciences · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
35 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • Fetuin-A
  • OPG
  • Metformin
  • Pioglitazone
03

In context

Diabetes Mellitus

10,923 studies on the registry are indexed under Diabetes Mellitus; 1,318 are open to participants now.

This study's enrollment of 102 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Newly diagnosed type 2 diabetes patients based on American Diabetes Association criteria (2011) for diagnosis of diabetes

Exclusion criteria

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.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Active comparator
    Metformin

    patients receiving fixed dose metformin 1000 mg daily

    Drug: Metformin

  • Active comparator
    Pioglitazone

    patients receiving fixed dose pioglitazone 30 mg daily

    Drug: Pioglitazone

Interventions

  • DrugMetformin

    Metformin 1000 mg fixed dose, twice daily (500 mg tablets x 2)

  • DrugPioglitazone

    Pioglitazone 30 mg fixed dose, twice daily (15 mg tablets x 2)

06

What researchers measure

Primary outcomes

  1. Serum concentrations of fetuin-A

    Time frame: 12 weeks

  2. Serum concentrations of osteoprotegrin

    Time frame: 12 weeks

07

Study locations

1 site
  • Diabetes Clinic, Vali-Asr Hospital, Tehran University of Medical Sciences
    Tehran, 13145-784, Iran, Islamic Republic of
08

References and documents

Publications

  • 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. PubMed 25450818 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02027103
Lead sponsor
Tehran University of Medical Sciences
Responsible party
Alireza Esteghamati (Alireza Esteghamati, M.D., Tehran University of Medical Sciences) — Principal investigator
First posted
Jan 3, 2014
Start date
Jan 2012
Primary completion
Mar 2012
Completion
Apr 2012
Last update
Jan 3, 2014

Study contacts

Alireza Esteghamati, M.D
principal investigator · Tehran University of Medical Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.

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