UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prognosis of diabetic patients on dialysis
Title of the study (Brief title)	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	Michio Kuwahara
Organization	Shuuwa General Hospital
Division name	Department of Nephrology
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	Michio Kuwahara
Organization	Shuuwa General Hospital
Division name	Department of Nephrology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2004 Year 03 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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