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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019282
Receipt No. R000022295
Scientific Title Prognosis of diabetic patients on dialysis
Date of disclosure of the study information 2015/10/08
Last modified on 2017/05/17

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Basic information
Public title Prognosis of diabetic patients on dialysis
Acronym Prognosis of diabetic patients on dialysis
Scientific Title Prognosis of diabetic patients on dialysis
Scientific Title:Acronym Prognosis of diabetic patients on dialysis
Region
Japan

Condition
Condition Diabetic endstage kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the prognosis of diabetic dialysis patients by the difference in treatment.
Basic objectives2 Others
Basic objectives -Others To determine the effects of cardiovascular events on the prognosis of diabetic dialysis patients.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of the survival rates of diabetic dialysis patients by the difference in treatment
Key secondary outcomes The relationship between the survival rates of diabetic dialysis patients and the history of cardiovascular events.

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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
95 years-old >=
Gender Male and Female
Key inclusion criteria Type II diabetic patients on hemodialysis were divided into the following 3 groups.
Group 1: Patients for whom diabetes treatment was reduced within 1 year before dialysis induction.
Group 2: Patients for whom diabetes was consistently treated with insulin or oral diabetes drugs before and after dialysis initiation.
Group 3: Patients for whom diabetes was consistently treated with diet therapy alone.
Key exclusion criteria patients complicated with serious diseases such as malignancy and multiple myeloma
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michio Kuwahara
Organization Shuuwa General Hospital
Division name Department of Nephrology
Zip code
Address 1200 Yahara-Shinden, Kasukabe, Saitama 344-0035, Japan
TEL 048-737-2121
Email kuwaharam@shuuwa-gh.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michio Kuwahara
Organization Shuuwa General Hospital
Division name Department of Nephrology
Zip code
Address 1200 Yahara-Shinden, Kasukabe, Saitama 344-0035, Japan
TEL 048-737-2121
Homepage URL
Email kuwaharam@shuuwa-gh.or.jp

Sponsor
Institute Shuuwa General Hospital
Institute
Department

Funding Source
Organization Shuuwa General Hospital
Organization
Division
Category of Funding Organization Other
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
2015 Year 10 Month 08 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
Our study was performed on the premise that the severity of the diabetic patients in the three groups was equal. Therefore we compared factors that are likely to be indicators of diabetes severity, such as the course of HbA1c levels and the degree of a treatment regimen in the early stages of diabetes, and the extent of diabetic retinopathy. However, the progress of HbA1c level and the treatment of regimen of diabetes showed a significant difference within the three groups. In addition, only one third of all patients were evaluated the degree of diabetic retinopathy by ophthalmologists. For these reasons, we had to abandon this study during the research period.
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 Terminated
Date of protocol fixation
2004 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2004 Year 04 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We compare the prognosis of dialysis patients among 3 groups, namely diabetic patients who were treated with only diet therapy before and after dialysis, diabetic patients who were treated with insulin or oral diabetis drug before and after dialysis, and diabetic patients whose treatment of diabetes was reduced within 1 year of the initiation of dialysis.
This is a cohort study. Subjects of this study are all patients who are received maintenance dialysis in our clinic after April 8, 2004. We measured hemoglobin, albumin, alkaline phosphatase, calcium, phosphate, hemoglobin A1c, and eGFR just before the initiation of dialysis.

Management information
Registered date
2015 Year 10 Month 08 Day
Last modified on
2017 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022295

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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