UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The observational study of diabetic nephropathy with microalbuminuria in the Tsugaru resion
Title of the study (Brief title)	The observational study of diabetic nephropathy with microalbuminuria in the Tsugaru resion (TSUGARU Study)
Region	Japan

Condition
Condition	The patients of diabetic nephropathy with microalbuminuria
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the rate of remission and progression from microalbuminuria in patients with type 2 diabetes, and the factors associated with remission and progression of diabetic nephropathy
Basic objectives2	Others
Basic objectives -Others	To clarify the rate of remission and progression from microalbuminuria in patients with type 2 diabetes, and the factors associated with remission and progression of diabetic nephropathy
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The rate of remission (norm albuminuria), and the rate of progression (overt proteinuria) at 36 months after the registration
Key secondary outcomes	The investigation of the factors contributed to remission and progression at 36 months after the registration

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The patients of diabetic nephropathy with microalbuminuria(30~300 mg/gCr)
Key exclusion criteria	The patients of diabetic nephropathy with albuminuria(less than 30 mg/gCr or over 300 mg/gCr)
Target sample size	317

Research contact person
Name of lead principal investigator	Norio Nakamura
Organization	Hirosaki University Graduate School of Medicine
Division name	Community Medicine
Address	Zaifu-cho 5, Hirosaki-city
TEL	0172-39-5057
Email	nnakamur@r2.dion.ne.jp

Public contact
Name of contact person	Norio Nakamura
Organization	Hirosaki University Graduate School of Medicine
Division name	Community Medicine
Address	Zaifu-cho 5, Hirosaki-city
TEL	0172-39-5057
Homepage URL
Email	nnakamur@r2.dion.ne.jp

Sponsor
Institute	Community Medicine, Hirosaki University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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	弘前大学医学部附属病院/ Hirosaki University Hospital

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 03 Month 28 Day
Anticipated trial start date	2011 Year 03 Month 28 Day
Last follow-up date	2015 Year 03 Month 31 Day
Date of closure to data entry	2015 Year 03 Month 31 Day
Date trial data considered complete	2015 Year 08 Month 10 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results	The rate of remission from microalbuminuria was 27.4 %, and the rate of progression from microalbuminuria was 13.7 % at 36 months after the registration.
Other related information	The rate of remission from microalbuminuria was 27.4 %, and the rate of progression from microalbuminuria was 13.7 % at 36 months after the registration.

Management information
Registered date	2016 Year 04 Month 28 Day
Last modified on	2016 Year 04 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025505