UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019282
Receipt number 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 16:53:53

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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 or person

Institute

Shuuwa General Hospital

Institute

Department

Personal name



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

Value
https://center6.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