UMIN-CTR Clinical Trial

Basic information
Public title	Monitoring of plasma glucose using continuous glucose measurement system (CGMs) in patients with peritoneal dialysis
Acronym	Continuous glucose measurement system (CGMs) in patients with peritoneal dialysis
Scientific Title	Monitoring of plasma glucose using continuous glucose measurement system (CGMs) in patients with peritoneal dialysis
Scientific Title:Acronym	Continuous glucose measurement system (CGMs) in patients with peritoneal dialysis
Region	Japan

Condition
Condition	peritoneal dialysis patients
Classification by specialty	Medicine in general Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We assess the effect of over sugar exposure from peritoneal dialysis fluid to systemic glucose dynamics in patients with peritoneal dialysis. Further, we assess the efficacy of Vildagliptin in patients with type 2 diabetes mellitus under peritoneal dialysis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Plasma glucose profiling using CGM
Key secondary outcomes	1) blood parameters: CBC, biochemistry, HbA1c, GA, beta2 MG, MDA-LDL 2) fasting glood glusoce 3) ABI 4) peritoneal equilibration test

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Start with once-daily dosing of vildagliptin 50mg, and increase up to twice a day 50 mg if effect of vilidagliptin on the clinical parameters is insufficient.
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	ESRD patients under CAPD treatment for more than three months
Key exclusion criteria	Acute renal failure, severe liver dysfunction, peritonitis, perioperative patients , serious trauma, unstable heart disorder or cerebrovascular disease, infection, malignant tumor, pregnant women or women suspected of being pregnant, the subjects found offensive by attending physicians for this research, hypersensitivity with the DPP-4 inhibitor, history of diabetic ketoacidosis or diabetic coma, type I diabetes mellitus, taking the drug which is contraindicated to combination vildagliptin
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Yukio Middle name Last name Yuzawa
Organization	Fujita Health University School of Medicine
Division name	Department of Nephrology
Zip code	4701192
Address	1-98 Dengakugakubo, Kutsukake, Toyoake
TEL	0562-93-9245
Email	yukio-y@fujita-hu.ac.jp

Public contact
Name of contact person	1st name Shigehisa Middle name Last name Koide
Organization	Fujita Health University School of Medicine
Division name	Department of Nephrology
Zip code	4701192
Address	1-98 Dengakugakubo, Kutsukake, Toyoake
TEL	0562-93-9245
Homepage URL
Email	skoide@fujita-hu.ac.jp

Sponsor
Institute	Department of Nephrology, Fujita Health University School of Medicine
Institute
Department

Funding Source
Organization	Department of Nephrology, Fujita Health University School of Medicine
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	Fujita Health University School of Medicine
Address	1-98 Dengakugakubo, Kutsukake, Toyoake
Tel	0562-93-2111
Email	chiken@fujita-hu.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	岡崎市民病院 Okazaki city hospital

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 21 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	Completed
Date of protocol fixation	2013 Year 07 Month 30 Day
Date of IRB	2014 Year 01 Month 01 Day
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date	2021 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 08 Month 21 Day
Last modified on	2022 Year 02 Month 25 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017349