UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000000689
Receipt number R000000828
Scientific Title Effect of pioglitazone on renal function amelioration by measurement of cystatine C levels in the type 2 diabetic patients
Date of disclosure of the study information 2008/03/31
Last modified on 2010/07/05 10:23:03

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Basic information

Public title

Effect of pioglitazone on renal function amelioration by measurement of cystatine C levels in the type 2 diabetic patients

Acronym

Effect of pioglitazone on renal function amelioration in the type 2 diabetic patients

Scientific Title

Effect of pioglitazone on renal function amelioration by measurement of cystatine C levels in the type 2 diabetic patients

Scientific Title:Acronym

Effect of pioglitazone on renal function amelioration in the type 2 diabetic patients

Region

Japan


Condition

Condition

Diabetic nephropathy

Classification by specialty

Endocrinology and Metabolism Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Examination of renal protective effect by pioglitazone on the progression of type 2 diabetic nephropathy by measurement of cystatine C levels

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

cystatine C, creatinine clearance, albumin extcretion rate, creatinine

Key secondary outcomes

general biochemical tests, HOMA-R, fasting blood insulin, serum resistin, CRP, adiponectin, leptin levels


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

pioglitazone 15-30mg/day

Interventions/Control_2

metformin 750mg/day

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1)The patients who were diagnosed as type 2 diabetic nephropathy (stage II-IV)
2)Less than HbA1c 9.0 %

Key exclusion criteria

1)The patient that it is already taken thiazolidinedione.
2)The patient with serious liver functional dysfunction.
3)Gravida or the patient with pregnant likelihood.
4)It is the patient with irritation for thiazolidinedione.

Target sample size

70


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name EITARO NAKASHIMA

Organization

Nagoya University Graduate School of Medicine

Division name

Department of Endocrinology and Diabetes

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya

TEL

052-744-2142

Email



Public contact

Name of contact person

1st name
Middle name
Last name EITARO NAKASHIMA

Organization

Nagoya University Hospital

Division name

Department of Endocrinology and Diabetes

Zip code


Address

65 Tsurumai-cho, Showa-ku, Nagoya

TEL

052-744-2142

Homepage URL


Email

eitaro@med.nagoya-u.ac.jp


Sponsor or person

Institute

Department of Endocrinology and Diabetes,
Nagoya University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

NONE

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2008 Year 03 Month 31 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2006 Year 12 Month 15 Day

Date of IRB


Anticipated trial start date

2007 Year 05 Month 01 Day

Last follow-up date

2008 Year 06 Month 01 Day

Date of closure to data entry

2008 Year 08 Month 01 Day

Date trial data considered complete

2008 Year 09 Month 01 Day

Date analysis concluded

2008 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2007 Year 04 Month 25 Day

Last modified on

2010 Year 07 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000828


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name