UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048429 |
|---|---|
| Receipt number | R000055193 |
| Scientific Title | Plasma glyceraldehyde level in healthy subjects after glucose or fructose injestion |
| Date of disclosure of the study information | 2022/08/08 |
| Last modified on | 2023/07/24 10:08:56 |
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Basic information
Public title
Plasma glyceraldehyde level in healthy subjects after glucose or fructose injestion
Acronym
Plasma glyceraldehyde level in healthy subjects after glucose or fructose injestion
Scientific Title
Plasma glyceraldehyde level in healthy subjects after glucose or fructose injestion
Scientific Title:Acronym
Plasma glyceraldehyde level in healthy subjects after glucose or fructose injestion
Region
| Japan |
Condition
Condition
healthy subjects
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of plasma glyceraldehyde levels after glucose or fructose injestion.
Basic objectives2
Others
Basic objectives -Others
Assessment of plasma glyceraldehyde levels after glucose or fructose injestion.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma glyceraldehyde levels after oral glucose/ fructose tolerance test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Take high dose glucose.
Interventions/Control_2
Take high dose fructose.
Interventions/Control_3
Take low dose glucose.
Interventions/Control_4
Take high dose fructose.
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
Those who received sufficient explanation about the trial, volunteered to participate after understanding the purpose, and agree to participate with written consent.
Key exclusion criteria
1.Herditary fructose intolerance
2.History of gastrointestinal surgery
3.Under treatment of diabetes, hypertension, hyperlipidemia, or hyperuricemia
4.History of cerebrovascular disease or cardiovascular disease
5.Severe impairment of liver function or liver cirrhosis
6.Severe impairment of renal function
7.Under corticosteroid therapy
8.During pregnancy or lactation period
Target sample size
20
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
Graduate School of Medicine, Kyoto University
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
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
| 2022 | Year | 08 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055193
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
