UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038124 |
|---|---|
| Receipt number | R000043429 |
| Scientific Title | Prospective observational study of the effect of nutrient intake on glucose metabolism through the Circadian rhythm |
| Date of disclosure of the study information | 2019/09/26 |
| Last modified on | 2023/03/30 17:05:54 |
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Basic information
Public title
Prospective observational study of the effect of nutrient intake on glucose metabolism through the Circadian rhythm
Acronym
Prospective observational study of the effect of nutrient intake on glucose metabolism through the Circadian rhythm
Scientific Title
Prospective observational study of the effect of nutrient intake on glucose metabolism through the Circadian rhythm
Scientific Title:Acronym
Prospective observational study of the effect of nutrient intake on glucose metabolism through the Circadian rhythm
Region
| Japan |
Condition
Condition
Type 1 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the timing and length of meals and sleep, and how meal content and sleep quality are related to glucose metabolism in diabetics
Basic objectives2
Others
Basic objectives -Others
To evaluate the timing and length of meals and sleep, and how meal content and sleep quality are related to glucose metabolism in diabetics
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area Under the Curve after sleep
Key secondary outcomes
Sleep quality
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
type 1 diabetes, insulin-dependent-state and treated with basal-bolus therapy or continuous subcutaneous insulin infusion
Key exclusion criteria
liver failure, renal insufficiency (eGFR > 30 mL/min/1.73m2), arrhythmia, taking steroid medication, taking sleep medication, using of continuous positive airway pressure therapy, psychological comorbidities or dementia, cancer-bearing, pregnant or breastfeeding, heavy drinker, received pancreas or islet transplantation, night shift worker
Target sample size
40
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 (iACT)
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 | Aki |
| Middle name | |
| Last name | Kondo |
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
akondo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Society For The Promotion Of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto university graduate school and faculty of medicine Kyoto university hospital Ethic committe
Address
Yoshida konoe-cho, Sakyo-ku, Kyoto-shi, 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
京都大学医学部附属病院（京都府）、御所南はらしまクリニック（京都府）、京都桂病院（京都府）、京都田辺中央病院（京都府）、高槻赤十字病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 26 | 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
44
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
| 2019 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Continuous blood glucose monitor, activity monitor, electroencephalogram monitor, heart rate variability monitor, meal record, etc. are performed for 4 days.
Management information
Registered date
| 2019 | Year | 09 | Month | 26 | Day |
Last modified on
| 2023 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043429
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
