UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045582 |
|---|---|
| Receipt number | R000051611 |
| Scientific Title | Examination of Various Endogenous glucose-related hormones and glycemic variability in patients with Type 2 Diabetes Mellitus Undergoing Hemodialysis |
| Date of disclosure of the study information | 2021/09/27 |
| Last modified on | 2021/09/27 22:10:50 |
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Basic information
Public title
Examination of Various Endogenous glucose-related hormones and glycemic variability in patients with Type 2 Diabetes Mellitus Undergoing Hemodialysis
Acronym
EVET2H study
Scientific Title
Examination of Various Endogenous glucose-related hormones and glycemic variability in patients with Type 2 Diabetes Mellitus Undergoing Hemodialysis
Scientific Title:Acronym
EVET2H study
Region
| Japan |
Condition
Condition
End stage renal disease
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For hemodialysis cases, perform a cookie meal test during hemodialysis to confirm blood glucose fluctuations, insulin and glucagon secretions
Basic objectives2
Others
Basic objectives -Others
Confirm blood glucose fluctuation and hormonal secretions due to dietary load during hemodialysis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the curve of pancreatic glucagon level measurements
Key secondary outcomes
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
Over 20 years old
Patients undergoing hemodialysis
Patients who have obtained written consent from the person
Key exclusion criteria
Patients who have taken oral hypoglycemic agents, insulin preparations, or GLP-1 receptor agonists within the past 7 days at the time of obtaining consent
Long hemodialysis time, more than 4 hours
Patients with allergies to wheat, butter, maltose, chicken eggs, soybeans, peaches, apples, walnuts, peanuts (which may be included in the manufacturing ingredients) and Mealtest S
Patients with markedly impaired swallowing function
Patients using a pacemaker
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masao |
| Middle name | |
| Last name | Toyoda |
Organization
Tokai University School of Medicine
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL
0463-93-1121
m-toyoda@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Kanori |
| Middle name | |
| Last name | Iwamatsu |
Organization
Tokai University School of Medicine
Division name
Division of Nephrology, Endocrinology and Metabolism
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
TEL
0463-93-1121
Homepage URL
k-iwamtsu@tsc.u-tokai.ac.jp
Sponsor or person
Institute
Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
The Japan Research Foundation for Healthy Aging
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research, Tokai University
Address
143 Shimokasuya, Isehara, Kanagawa 259-1193, JAPAN
Tel
0463-93-1121
tokai-tokutei@ml.u-tokai.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
| 2021 | Year | 09 | Month | 27 | 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
| 2021 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study / Crossover study
Management information
Registered date
| 2021 | Year | 09 | Month | 27 | Day |
Last modified on
| 2021 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051611
