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 | 2026/05/01 14:15:20 |
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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 how meal timing and nutritional composition, as well as the timing, duration, and quality of sleep, are associated with glucose metabolism in patients with diabetes.
Basic objectives2
Others
Basic objectives -Others
To evaluate how glycemic variability, insulin dosing, and autonomic nervous system activity are associated with sleep quality in patients with diabetes.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
area under the glucose curve after bedtime
Key secondary outcomes
sleep quality
Analysis methods:
Using daily data collected over 4 consecutive days, the associations of nutritional composition, timing of the last meal, and the interval between the last meal and bedtime with the area under the glucose curve after bedtime will be evaluated. In addition, as secondary analyses, the associations of glycemic variability, insulin dosing, and autonomic nervous system activity with sleep quality will be examined. Analyses will be conducted on a day-level basis using generalized estimating equations (GEE) to account for within-subject correlations in repeated measurements.
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
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
44
Results
Later dinner time, higher dinner carbohydrate intake, and lower protein intake were associated with a higher area under the glucose curve (AUC) after bedtime. A higher AUC after was associated with prolonged sleep onset latency and a reduced proportion of deep sleep (N3/TST). In addition, a higher LF/HF after bedtime-an index of sympathetic predominance derived from heart rate variability-was also associated with lower N3/TST. Furthermore, the last bolus insulin dose was positively associated with LF/HF.
Results date posted
| 2026 | Year | 05 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 44 participants provided informed consent, of whom 5 withdrew consent. Among the 39 participants who completed data collection, 17 were male and 22 were female; the median age was 51.0 years, the median duration of diabetes was 15.0 years, the median HbA1c was 7.6%, and the median BMI was 22.5 kg/m2.
Participant flow
For each participant, data on continuous glucose monitoring, dietary records, sleep electroencephalography, heart rate variability, and physical activity were collected over four consecutive days. Of the 39 participants, 1 was excluded due to a reversed sleep-wake cycle. For the primary outcome analysis, 3 participants with no available continuous glucose monitoring, dietary records, or heart rate variability data across all 4 days were excluded, leaving 35 participants for analysis. This resulted in a total of 140 participant-days of data. Of these, days with insufficient data for analysis, including missing continuous glucose monitoring data, were excluded, resulting in 88 participant-days (from 32 participants) for the final analysis.
Adverse events
None
Outcome measures
Primary outcome: Area under the glucose curve after bedtime
Secondary outcome: Sleep quality
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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 | 11 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 09 | Month | 26 | Day |
Last modified on
| 2026 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043429
