UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050752 |
|---|---|
| Receipt number | R000057830 |
| Scientific Title | The exploration of the implication of measuring the concentration of isoxanthopterine in urine with type 2 diabetes mellitus and metabolic syndrome. |
| Date of disclosure of the study information | 2023/04/27 |
| Last modified on | 2025/05/12 11:24:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The exploration of the concentration of isoxanthopterine in urine with type 2 diabetes mellitus and metabolic syndrome.
Acronym
The exploration of the concentration of isoxanthopterine in urine with type 2 diabetes mellitus and metabolic syndrome.
Scientific Title
The exploration of the implication of measuring the concentration of isoxanthopterine in urine with type 2 diabetes mellitus and metabolic syndrome.
Scientific Title:Acronym
The explaration of the implication of measuring the concentration of isoxanthopterine in urine with type 2 diabetes mellitus and metabolic syndrome.
Region
| Japan |
Condition
Condition
Obesity, Type 2 diabetes mellitus and metabolic syndrome
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of our study is to measure isoxanthopterin in serum and urine in healthy volunteer, type 2 diabetes mellitus and metabolic syndrome and to explore new biomarker for oxidative stress which effective in understanding the pathology with endocrine and metabolic disease like that type 2 diabetes mellitus.
Basic objectives2
Others
Basic objectives -Others
observation, compare
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
urine isoxanthopterin consentration
Key secondary outcomes
alanine aminotransferase:ALT, insulin resistance
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
| 18 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Obese, type 2 diabetes and metabolic syndrome patients who are currently attending the University of the Ryukyus Hospital and affiliated hospital and healthy volunteer.
Key exclusion criteria
Patients who are assessed by the attending physician to be inappropriate for the study.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | None |
| Last name | Masuzaki |
Organization
Graduate School of Medicine, University of the Ryukyus.
Division name
Division of Endocrinology, Diabetes and Metabolism,Hematology, Rheumatology.
Zip code
903-0215
Address
207 Uehara, Nishihara, Okinawa
TEL
098-895-1146
hiroaki@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Rei |
| Middle name | None |
| Last name | Chinen |
Organization
Graduate School of Medicine, University of the Ryukyus.
Division name
Division of Endocrinology, Diabetes and Metabolism,Hematology, Rheumatology.
Zip code
903-0215
Address
207 Uehara, Nishihara, Okinawa
TEL
098-895-1146
Homepage URL
reda461@ryudai2nai.com
Sponsor or person
Institute
University of the Ryukyus.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Teijin Pharma Limited, Tokyo, Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Ryukyus
Address
207 Uehara, Nishihara, Okinawa
Tel
098-895-1542
krinken@acs.u-ryukyu.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
| 2023 | Year | 04 | 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
51
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The participants in the present study meet the criteria and in the University of the Ryukyus Hospital and related facilities during the period from the respective date of ethical review approval by the Ethics Committee of University of the Ryukyus for Medical and Health Research Involving Human Subjects to March 31, 2024. We aim to measure and compare isoxanthopterin in serum and urine in healthy volunteer, type 2 diabetes mellitus and metabolic syndrome and to use for biomarker forecasting increse of oxidative strss and observe therapeutic effect.
Management information
Registered date
| 2023 | Year | 04 | Month | 03 | Day |
Last modified on
| 2025 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057830
