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

NCT ID: NCT01799850

Last Updated: 2013-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2004-03-31

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.

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.

Conditions

Diabetes Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Actos

Actos 30 mg daily

Group Type: ACTIVE_COMPARATOR

Pioglitazone

Intervention Type: DRUG

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

placebo

double blind placebo controlled

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo assigned randomly, double blind

Interventions

Pioglitazone

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

Intervention Type: DRUG

placebo

placebo assigned randomly, double blind

Intervention Type: DRUG

Other Intervention Names

Actos or placebo; sugar pill

Eligibility Criteria

Inclusion Criteria

• diabetes, type 2
• HbA1c less than 8.5

Exclusion Criteria

• insulin therapy
• renal insufficiency
• clinically apparent coronary disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Takeda Pharmaceuticals North America, Inc.

INDUSTRY

Sponsor Role: collaborator

East Tennessee State University

OTHER

Sponsor Role: lead

Responsible Party

Charles A. Stuart

Professor, Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charles A Stuart, MD

Role: PRINCIPAL_INVESTIGATOR

ETSU Quillen College of Medicine

Locations

ETSU Quillen College of Medicine

Johnson City, Tennessee, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 17251278 (View on PubMed)

Other Identifiers

TPNA 02-037A

Identifier Type: -

Identifier Source: org_study_id