NCT01799850

Brief Summary

Subjects with type 2 diabetes will be treated with Actos or placebo for eight weeks and needle biopsies of muscle will quantify changes in any of seven different glucose transport proteins in muscle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2002

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

March 1, 2002

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
8.1 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2012

Completed
11 months until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
Last Updated

February 27, 2013

Status Verified

February 1, 2013

Enrollment Period

2 years

First QC Date

March 20, 2012

Last Update Submit

February 25, 2013

Conditions

Diabetes Type 2

Keywords

muscleglucose transportersGLUT4GLUT5Actos

Outcome Measures

Primary Outcomes (1)

  • change in muscle glucose transporter expression

    immunoblots pre and post, placebo and Actos

    post eight weeks treatment

Study Arms (2)

Actos

ACTIVE COMPARATOR

Actos 30 mg daily

Drug: Pioglitazone

placebo

PLACEBO COMPARATOR

double blind placebo controlled

Drug: placebo

Interventions

PioglitazoneDRUG

pioglitazone 30 mg daily, pill, eight weeks, placebo randomly assigned

Also known as: Actos or placebo
Actos
placeboDRUG

placebo assigned randomly, double blind

Also known as: sugar pill
placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diabetes, type 2
  • HbA1c less than 8.5

You may not qualify if:

  • insulin therapy
  • renal insufficiency
  • clinically apparent coronary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ETSU Quillen College of Medicine

Johnson City, Tennessee, 37614, United States

Location

Related Publications (1)

  • Stuart CA, Howell ME, Yin D. Overexpression of GLUT5 in diabetic muscle is reversed by pioglitazone. Diabetes Care. 2007 Apr;30(4):925-31. doi: 10.2337/dc06-1788. Epub 2007 Jan 24.

    PMID: 17251278RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

PioglitazoneSugars

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbohydrates

Study Officials

  • Charles A Stuart, MD

    ETSU Quillen College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Internal Medicine

Study Record Dates

First Submitted

March 20, 2012

First Posted

February 27, 2013

Study Start

March 1, 2002

Primary Completion

March 1, 2004

Study Completion

March 1, 2004

Last Updated

February 27, 2013

Record last verified: 2013-02

Locations

US(1)