The Impact of Actos Treatment of Diabetes on Glucose Transporters in Muscle

February 25, 2013 updated by: Charles A. Stuart, East Tennessee State University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Twelve subjects with type 2 diabetes, with fair control on oral medication, will be recruited to participate in a randomized, double-blind, placebo-controlled study of the impact on muscle glucose transporter expression of the addition of the insulin-sensitizing agent, pioglitizone (Takeda Pharmaceuticals). Therapy with the active drug will be at 30 mg daily. The other oral medications will be adjusted downward if hypoglycemia occurs. Glycemic control will be monitored by at least twice daily home blood glucose monitoring, weekly telephone contacts, and follow-up visits to the ETSU/VAMC Clinical Research Unit (CRU) every two weeks. During the eight weeks of therapy, subjects will be instructed to maintain their weight and keep their dietary and exercise regimens unchanged. Muscle biopsies will be obtained before and at the end of eight weeks of therapy. Specimens will be assayed for GLUT1, GLUT3, GLUT4, GLUT5, GLUT8, GLUT11, and GLUT12 mRNA and protein content and the subcellular distribution of these proteins as described below. Peroxisome proliferator-activated receptor gamma (PPARgamma), a member of the ligand-activated nuclear hormone receptor superfamily (14), will be quantified in these specimens by immunoblot as described below.

This study design involving a randomized, double-blinded, placebo-controlled treatment regimen is needed to control for confounding variables causing changes in glucose transporter expression that may be erroneously attributed to the drug. These potential variables include close contact with the diabetes management team resulting in improved compliance with diet, exercise, medication, and monitoring and thus better glycemic control, weight loss, or improved fitness.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Johnson City, Tennessee, United States, 37614
        • Etsu Quillen College Of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • diabetes, type 2
  • HbA1c less than 8.5

Exclusion Criteria:

  • insulin therapy
  • renal insufficiency
  • clinically apparent coronary disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Actos
Actos 30 mg daily
Drug: Pioglitazone
pioglitazone 30 mg daily, pill, eight weeks, placebo randomly assigned
Other Names:
  • Actos or placebo
Placebo Comparator: placebo
double blind placebo controlled
Drug: placebo
placebo assigned randomly, double blind
Other Names:
  • sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in muscle glucose transporter expression
Time Frame: post eight weeks treatment
immunoblots pre and post, placebo and Actos
post eight weeks treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

East Tennessee State University

Collaborators

Takeda Pharmaceuticals North America, Inc.

Investigators

  • Principal Investigator: Charles A Stuart, MD, Etsu Quillen College Of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

March 1, 2004

Study Completion (Actual)

March 1, 2004

Study Registration Dates

First Submitted

March 20, 2012

First Submitted That Met QC Criteria

February 25, 2013

First Posted (Estimate)

February 27, 2013

Study Record Updates

Last Update Posted (Estimate)

February 27, 2013

Last Update Submitted That Met QC Criteria

February 25, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPNA 02-037A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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