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How Does the Diabetes Drug, Pioglitazone, Reduce Protein Loss in the Urine?

NCT00749047 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2009-09-16

No results posted yet for this study

Summary

Pioglitazone is an insulin sensitising drug used in the treatment of patients with type 2 diabetes. In addition to its blood sugar lowering effect, pioglitazone also has a number of other beneficial effects, one of which is to reduce the loss of protein in the urine. The mechanism of this protein "sparing effect" of pioglitazone is not fully understood. The proposed study will investigate whether pioglitazone has beneficial effects on the filtration characteristics of filters in the kidney that are responsible for retaining protein in the body. The effect of pioglitazone on the size of the pores in the filters and also the electrostatic charge barriers that surround these pores will be investigated. The clinical study will involve 12 patients with type 2 diabetes with minimal urine protein loss, taking low dose pioglitazone for 3 months. Blood and urine samples will be collected at the beginning, mid point and end of the study and used to measure the concentration of specific proteins of different size and electrostatic charge. This data will be used to identify and characterise changes in the filtration properties of the kidney filters during the study.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Pioglitazone

15-45 mg/day

Sponsors & Collaborators

  • Christchurch Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-12-31
Completion
2010-03-31

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00749047 on ClinicalTrials.gov