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

NCT00749047 | Unknown Phase 4

• 1 other identifier: H6E-AY-O017
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pioglitazone; Open study; Proteinuria; Glomerular selectivity indices

Outcome Measures

Primary Outcomes (1)

• Reduction in proteinuria

  3 months

Secondary Outcomes (1)

• Reduction in non-fasting plasma glucose concentration

  3 months

Study Arms (1)

1

EXPERIMENTAL

Open label arm

Drug: Pioglitazone

Interventions

Pioglitazone DRUG

15-45 mg/day

Also known as: Actos, Batch number A490463

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes mellitus, Type 2
• Age 18-70 yrs

You may not qualify if:

• Overt proteinuria (urine albumin:creatinine ratio \>10.0
• Plasma creatinine 0.15 mmol/L
• HbA1c \>10%
• Hear failure Class III or IV
• Peripheral oedema
• Abnormal liver function (serum AST \>2.5 times upper limit of normal)
• Pregnancy or breastfeeding
• History of urinary tract infections
• Serious concomitant disorder

Sponsors & Collaborators

• Christchurch Hospital: lead

Study Sites (1)

Christchurch Hospital

Christchurch, Canterbury, 8001, New Zealand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Proteinuria

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2008
• First Posted: September 9, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: September 16, 2009

Record last verified: 2009-09

Locations

NZ (1)