NCT02027103

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Jan 2012

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 3, 2014

Completed
Last Updated

January 3, 2014

Status Verified

January 1, 2014

Enrollment Period

2 months

First QC Date

January 2, 2014

Last Update Submit

January 2, 2014

Conditions

Type 2 Diabetes Mellitus

Keywords

Fetuin-AOPGMetforminPioglitazone

Outcome Measures

Primary Outcomes (2)

  • Serum concentrations of fetuin-A

    12 weeks

  • Serum concentrations of osteoprotegrin

    12 weeks

Study Arms (2)

Metformin

ACTIVE COMPARATOR

patients receiving fixed dose metformin 1000 mg daily

Drug: Metformin

Pioglitazone

ACTIVE COMPARATOR

patients receiving fixed dose pioglitazone 30 mg daily

Drug: Pioglitazone

Interventions

MetforminDRUG

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

Metformin
PioglitazoneDRUG

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

Pioglitazone

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Diabetes Clinic, Vali-Asr Hospital, Tehran University of Medical Sciences

Tehran, 13145-784, Iran

Location

Related Publications (1)

  • 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.

    PMID: 25450818DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

MetforminPioglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsThiazolidinedionesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Alireza Esteghamati, M.D

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Alireza Esteghamati, M.D.

Study Record Dates

First Submitted

January 2, 2014

First Posted

January 3, 2014

Study Start

January 1, 2012

Primary Completion

March 1, 2012

Study Completion

April 1, 2012

Last Updated

January 3, 2014

Record last verified: 2014-01

Locations

IR(1)