UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014916 |
|---|---|
| Receipt number | R000017349 |
| Scientific Title | Monitoring of plasma glucose using continuous glucose measurement system (CGMs) in patients with peritoneal dialysis |
| Date of disclosure of the study information | 2014/08/21 |
| Last modified on | 2022/02/25 22:13:48 |
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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
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
skoide@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Nephrology, Fujita Health University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017349
