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

Diabetes Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799850
• Other study ID #: TPNA 02-037A
• Status: Completed
• Phase: Phase 4
• First received: March 20, 2012
• Last updated: February 25, 2013
• Start date: March 2002
• Est. completion date: March 2004

Study information

• Verified date: February 2013
• Source: East Tennessee State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• diabetes, type 2

• HbA1c less than 8.5

Exclusion Criteria:

• insulin therapy

• renal insufficiency

• clinically apparent coronary disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Diabetes Type 2

Intervention

Drug:
• Pioglitazone
pioglitazone 30 mg daily, pill, eight weeks, placebo randomly assigned
• placebo
placebo assigned randomly, double blind

Locations

Country	Name	City	State
United States	ETSU Quillen College of Medicine	Johnson City	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
East Tennessee State University	Takeda Pharmaceuticals North America, Inc.

Country where clinical trial is conducted

United States, 

References & 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. Epub 2007 Jan 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in muscle glucose transporter expression	immunoblots pre and post, placebo and Actos	post eight weeks treatment	No