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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Metformin; Drug: Pioglitazone

• Registration Number: NCT02027103
• Lead Sponsor: Tehran University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2012-03
• Study Completion: 2012-04
• Status Verified: 2014-01
• Study First Submitted: 2014-01-02
• Study First Submitted QC: 2014-01-02
• Last Update Submitted: 2014-01-02
• Study First Posted: 2014-01-03
• Last Update Posted: 2014-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metformin	Metformin	patients receiving fixed dose metformin 1000 mg daily
Pioglitazone	Pioglitazone	patients receiving fixed dose pioglitazone 30 mg daily

Primary Outcome Measures

Name	Time	Method
Serum concentrations of fetuin-A	12 weeks
Serum concentrations of osteoprotegrin	12 weeks

Trial Locations

Locations (1)

Diabetes Clinic, Vali-Asr Hospital, Tehran University of Medical Sciences; 🇮🇷 Tehran, Iran, Islamic Republic of