UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036647 |
|---|---|
| Receipt number | R000039229 |
| Scientific Title | Utility of a novel estimation method for hemoglobin A1c using glycated albumin in type 2 diabetes mellitus patients with end-stage renal disease |
| Date of disclosure of the study information | 2019/05/05 |
| Last modified on | 2019/05/04 10:49:08 |
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Basic information
Public title
Utility of a novel estimation method for hemoglobin A1c using glycated albumin in type 2 diabetes mellitus patients with end-stage renal disease
Acronym
Utility of a novel estimation method for hemoglobin A1c using glycated albumin in type 2 diabetes mellitus patients with end-stage renal disease
Scientific Title
Utility of a novel estimation method for hemoglobin A1c using glycated albumin in type 2 diabetes mellitus patients with end-stage renal disease
Scientific Title:Acronym
Utility of a novel estimation method for hemoglobin A1c using glycated albumin in type 2 diabetes mellitus patients with end-stage renal disease
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus patients with end-stage renal disease
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Sustained glucose measurement (Continuous Glucose Monitoring: CGM) in patients with type 2 diabetes mellitus patients with end-stage renal disease, estimation method for hemoglobin A1c using glycated albumin (Estimation method for hemoglobin A1c using glycated albumin: eHbA1c) and examine the usefulness of the relationship between blood glucose levels.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Average blood glucose level in Continuous Glucose Monitoring
Key secondary outcomes
HbA1c and GA after CGM
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetes patients
Over 20 years old,Male and Female
written informed consent
Key exclusion criteria
Type 1 diabetes patients
Patients having severe infections, before and after operation and trauma
Pregnancy
Patient who are inadequate to enter this study due to the other reasons by physicians judgments
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akihiko |
| Middle name | |
| Last name | Nakmura |
Organization
Osafune Clinic
Division name
Dean
Zip code
701-4264
Address
332-1 Haji,Osafune-cho,Setouti City,Japan
TEL
0869-26-8080
osafune-clinic@nifty.com
Public contact
Name of contact person
| 1st name | Yumi |
| Middle name | |
| Last name | Nasu |
Organization
Osafune Clinic
Division name
Deputy Nurse Head
Zip code
701-4264
Address
332-1 Haji,Osafune-cho,Setouti City,Japan
TEL
0869-26-8080
Homepage URL
http://www.osafune-clinic.com/chiken.ktml
osafune-clinic@nifty.com
Sponsor or person
Institute
Osafune Clinic
Institute
Department
Personal name
Funding Source
Organization
Self Funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osafune Clinic
Address
332-1 Haji,Osafune-cho,Setouti City,Japan
Tel
0869-26-8080
osafune-clinic@nifty.com
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
おさふねクリニック
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
Observational
Type 2 diabetic patients in outpatient, hemodialysis
Management information
Registered date
| 2019 | Year | 05 | Month | 04 | Day |
Last modified on
| 2019 | Year | 05 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039229
