Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00749047




Registration number
NCT00749047
Ethics application status
Date submitted
8/09/2008
Date registered
9/09/2008
Date last updated
16/09/2009

Titles & IDs
Public title
How Does the Diabetes Drug, Pioglitazone, Reduce Protein Loss in the Urine?
Scientific title
A Study on the Anti-proteinuric Effects of Pioglitazone in Patients With Type 2 Diabetes.
Secondary ID [1] 0 0
H6E-AY-O017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Pioglitazone

Experimental: 1 - Open label arm


Treatment: Drugs: Pioglitazone
15-45 mg/day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Reduction in proteinuria
Timepoint [1] 0 0
3 months
Secondary outcome [1] 0 0
Reduction in non-fasting plasma glucose concentration
Timepoint [1] 0 0
3 months

Eligibility
Key inclusion criteria
* Diabetes mellitus, Type 2
* Age 18-70 yrs
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2010
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Canterbury

Funding & Sponsors
Primary sponsor type
Other
Name
Christchurch Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00749047
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00749047