UMIN-CTR Clinical Trial

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
Email	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
Email	k-iwamtsu@tsc.u-tokai.ac.jp

Sponsor
Institute	Division of Nephrology, Endocrinology and Metabolism, Tokai University School of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051611