UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054118 |
|---|---|
| Receipt number | R000061761 |
| Scientific Title | Metabolic kinetics of glyceraldehyde and investigation of the relationship between glyceraldehyde and liver steatosis in patients with diabetes. |
| Date of disclosure of the study information | 2024/04/12 |
| Last modified on | 2024/04/11 13:28:54 |
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Basic information
Public title
Metabolic kinetics of glyceraldehyde and investigation of the relationship between glyceraldehyde and liver steatosis in patients with diabetes.
Acronym
Metabolic kinetics of glyceraldehyde and investigation of the relationship between glyceraldehyde and liver steatosis in patients with diabetes.
Scientific Title
Metabolic kinetics of glyceraldehyde and investigation of the relationship between glyceraldehyde and liver steatosis in patients with diabetes.
Scientific Title:Acronym
Metabolic kinetics of glyceraldehyde and investigation of the relationship between glyceraldehyde and liver steatosis in patients with diabetes.
Region
| Japan |
Condition
Condition
type2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the metabolic kinetics of glyceraldehyde in conditions of impaired glucose metabolism and to evaluate its association with diabetic complications, including steatotic liver disease.
Basic objectives2
Others
Basic objectives -Others
To clarify the metabolic kinetics of glyceraldehyde in conditions of impaired glucose metabolism and to evaluate its association with diabetic complications, including steatotic liver disease.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Glyceraldehyde levels before and after treatment of hyperglycemia
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Type2 diabetes patients over 18 years old
Key exclusion criteria
severe kidney dysfunction (eGFR under 30ml/min/1.73m2)
use of steroid
pregnant or breast-feeding
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Ikeda |
Organization
Kyoto University Hospital
Division name
Institute for Advancement of Clinical and Translational Science/Department of Diabetes, Endocrinology and Nutrition
Zip code
606-8507
Address
54 Shogoinkawahara-cho, Sakyo-ku,Kyoto-shi,Kyoto
TEL
075-751-3560
krikeda@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Ueba |
Organization
Graduate School of Medicine, Kyoto University
Division name
Department of Diabetes, Endocrinology and Nutrition
Zip code
606-8507
Address
54 Shogoinkawahara-cho, Sakyo-ku,Kyoto-shi,Kyoto
TEL
075-751-3560
Homepage URL
yokoueba@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2024 | Year | 04 | Month | 12 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 04 | Month | 11 | Day |
Last modified on
| 2024 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061761
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| Registered date | File name |
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