UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018707 |
|---|---|
| Receipt number | R000021647 |
| Scientific Title | Evaluation of the attribution of glycemic excursion after hemodialysis in patients with diabetes. |
| Date of disclosure of the study information | 2015/08/18 |
| Last modified on | 2019/08/21 06:55:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of the attribution of glycemic excursion after hemodialysis in patients with diabetes.
Acronym
Evaluation of the glycemic profile in patients with diabetes on hemodialysis.
Scientific Title
Evaluation of the attribution of glycemic excursion after hemodialysis in patients with diabetes.
Scientific Title:Acronym
Evaluation of the glycemic profile in patients with diabetes on hemodialysis.
Region
| Japan |
Condition
Condition
Patients with diabetes on hemodialysis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the attribution of glycemic excursion after hemodialysis in patients with diabetes by the difference of glycemic and hormonal profile between hemodialysis day and non-hemodialysis day.
Basic objectives2
Others
Basic objectives -Others
To evaluate the attribution of glycemic excursion after hemodialysis in patients with diabetes
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glycemic profile by using continuous glucose monitoring and contributing hormonal factors (Insulin, C-peptide, Glucagon, Growth hormone, ACTH, Cortisol)
Key secondary outcomes
HbA1c and glycated albumin
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
For admitted patients, in the situation of taking same meals at same time between hemodialysis day and non-hemodialysis day, the glycemic profiles were collected by continuous glucose monitoring and the hormonal data were collected by blood samplings.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Stable dialysis prescription, 2)Currently hospitalization
Key exclusion criteria
1)Fever over 37.0 degreeC or overt infection disease, 2)Active malignant tumors, 3)Treatment with oral steroids, 4)Complicated with diseases influencing glycemic profile (e.g.Cushing syndrome, acromegaly, insulinoma, and dumping syndrome), 5)Pregnancy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Akinori |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Endocrinology, Diabetes and Metabolism
Zip code
252-0374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-8706
ahayashi@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Akinori |
| Middle name | |
| Last name | Hayashi |
Organization
Kitasato University School of Medicine
Division name
Endocrinology, Diabetes and Metabolism
Zip code
252-0374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
TEL
042-778-8706
Homepage URL
ahayashi@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine. Division of Endocrinology, Diabetes and Metabolism.
Institute
Department
Personal name
Funding Source
Organization
Grant for Japanese Association of Dialysis Physicians and Self-funding
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
the Ethics Committee of Kitasato University Hospital
Address
1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, Japan
Tel
042-778-7756
onoya@kitasato-u.ac.jp
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 | 08 | Month | 18 | 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
Main results already published
Date of protocol fixation
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 08 | Month | 01 | Day |
Other
Other related information
From July 2015, the present study was performed. In the situation of taking same meals at same time between hemodialysis day and non-hemodialysis day, the glycemic profiles were collected by CGM and the hormonal data were collected by blood sampling.
Management information
Registered date
| 2015 | Year | 08 | Month | 18 | Day |
Last modified on
| 2019 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021647
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
