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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01799850
Recruitment Status : Completed
First Posted : February 27, 2013
Last Update Posted : February 27, 2013
Sponsor:
Collaborator:
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Charles A. Stuart, East Tennessee State University

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.

Condition or disease Intervention/treatment Phase
Diabetes Type 2 Drug: Pioglitazone Drug: placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Impact of Actos Treatment of Diabetes on Glucose Transporters in Muscle
Study Start Date : March 2002
Actual Primary Completion Date : March 2004
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Actos
Actos 30 mg daily
Drug: Pioglitazone
pioglitazone 30 mg daily, pill, eight weeks, placebo randomly assigned
Other Name: Actos or placebo

Placebo Comparator: placebo
double blind placebo controlled
Drug: placebo
placebo assigned randomly, double blind
Other Name: sugar pill




Primary Outcome Measures :
  1. change in muscle glucose transporter expression [ Time Frame: post eight weeks treatment ]
    immunoblots pre and post, placebo and Actos



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diabetes, type 2
  • HbA1c less than 8.5

Exclusion Criteria:

  • insulin therapy
  • renal insufficiency
  • clinically apparent coronary disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799850


Locations
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United States, Tennessee
ETSU Quillen College of Medicine
Johnson City, Tennessee, United States, 37614
Sponsors and Collaborators
East Tennessee State University
Takeda Pharmaceuticals North America, Inc.
Investigators
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Principal Investigator: Charles A Stuart, MD ETSU Quillen College of Medicine
Publications of Results:
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Responsible Party: Charles A. Stuart, Professor, Internal Medicine, East Tennessee State University
ClinicalTrials.gov Identifier: NCT01799850    
Other Study ID Numbers: TPNA 02-037A
First Posted: February 27, 2013    Key Record Dates
Last Update Posted: February 27, 2013
Last Verified: February 2013
Keywords provided by Charles A. Stuart, East Tennessee State University:
muscle
glucose transporters
GLUT4
GLUT5
Actos
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs