UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019144 |
|---|---|
| Receipt number | R000021763 |
| Scientific Title | Effects of consuming meals at different time of the day and different methods on postprandial blood glucose and hormone secretions in people with type 2 diabetes and normal glucose tolerance-Randomized cross-over study |
| Date of disclosure of the study information | 2015/09/30 |
| Last modified on | 2021/11/20 11:14:54 |
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Basic information
Public title
Effects of consuming meals at different time of the day and different methods on postprandial blood glucose and hormone secretions in people with type 2 diabetes and normal glucose tolerance-Randomized cross-over study
Acronym
Effects of consuming meals at different time of the day and different methods on postprandial blood glucose and hormone secretions in people with type 2 diabetes and normal glucose tolerance
Scientific Title
Effects of consuming meals at different time of the day and different methods on postprandial blood glucose and hormone secretions in people with type 2 diabetes and normal glucose tolerance-Randomized cross-over study
Scientific Title:Acronym
Effects of consuming meals at different time of the day and different methods on postprandial blood glucose and hormone secretions in people with type 2 diabetes and normal glucose tolerance
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this ranodmized cross-over study is to investigate the effects of consuming meals at different time of the day and different methods on postprandial blood glucose and hormone secretions in people with type 2 diabetes and normal glucose tolerance.
Basic objectives2
Others
Basic objectives -Others
We investigate the time and method of consuming meals to reduce the glucose fluctuations in people with and without type 2 diabetes.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Postprandial blood glucose and insulin at 0,30,60,and 120 min after consuming the
dinner on the each test day.
Key secondary outcomes
Area under the glucose curve, glucagon, GLP-1,GIP, FFA, and PYY at 0,30,60,and 120 min after consuming the dinnre on the each test day.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
This is a randomized, controlled, two-treatment, cross-over study. Five patients with T2DM and 5 subjects with NGT are assigned to consume the dinner separately at 18:00 and 21:00 on the first day, consume the dinner at 18:00 (washout day) on the second day, and consume the dinner at 21:00 on the third day . All participants are collected the blood samples at 0,30,60, and 120 min. Postprandial blood glucose, insulin, glucagon, GLP-1, GIP, PYY, and FFA are compared between 2 days.
Interventions/Control_2
Five patients with T2DM and 5 subjects with NGT are assigned to consume the dinner at 21:00 on the first day, consume the dinner at 18:00 (washout day),
and consume the dinner separately at 18:00 and 21:00 on the third day. All participants are collected the blood samples at 0,30,60, and 120 min. Postprandial blood glucose, insulin, glucagon, GLP-1, GIP, PYY, and FFA are compared between 2 days.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults patients with type 2 diabetes who are not treated with insulin.
Healty volunteers in whom previous blood and urinary glucose tests are normal.
Key exclusion criteria
Subjects who have liver disease, severe complications of diabetes, nephropathy, stroke, history of cerebral myocardial infaction, steroidal anti-inflammatory drugs,drug or alcohol abuse, and mental illness.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Saeko |
| Middle name | |
| Last name | Imai |
Organization
Kyoto Women's University
Division name
Department of Food and Nutrition
Zip code
605-8501
Address
35, Imakumano, Kitahiyoshi-cho, Higashiyama-ku, Kyoto
TEL
075-531-7128
imais@kyoto-wu.ac.jp
Public contact
Name of contact person
| 1st name | Saeko |
| Middle name | |
| Last name | Imai |
Organization
Kyoto Women's University
Division name
Department of Food and Nutrition
Zip code
605-8501
Address
35, Imakumano, Kitahiyoshi-cho, Higashiyama-ku, Kyoto
TEL
075-531-7128
Homepage URL
imais@kyoto-wu.ac.jp
Sponsor or person
Institute
Department of Food and Nutrition, Faculty of Home Economics,
Kyoto Women's University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion Science
KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kajiyama Clinic, Kyoto,Japan
Name of secondary funder(s)
Kyoto Women's University
IRB Contact (For public release)
Organization
Kyoto Women's University
Address
35, Imakumano, Kitahiyoshi-cho, Higashiyama-ku, Kyoto
Tel
075-531-7128
imais@kyoto-wu.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
梶山内科クリニック(京都市）Kajiyama Clinic, Kyoto,Japan
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S016882271730133X?via%3Dihub
Publication of results
Partially published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S016882271730133X?via%3Dihub, https://www.scienced
Number of participants that the trial has enrolled
28
Results
Late dinner demonstrated higher incremental glucose peak (IGP) and incremental area under the curve (IAUC) for glucose than early dinner. On the other hand, divided dinner ameliorated IGP and the mean amplitude of glycemic excursion (MAGE). Consuming late-night-dinner increased postprandial glucose and insulin levels, compared to divided dinner, suggesting divided dinner could be a practical strategy for reduction of postprandial glucose levels in people with and without diabetes.
Results date posted
| 2020 | Year | 04 | Month | 02 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Our research paper about dinner-time and hormone is still in press.
Date of the first journal publication of results
| 2017 | Year | 05 | Month | 16 | Day |
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Incremental area under the curve for glucose, incremental glucose peak, mean amplitude of glycemic excursion
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2015 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 09 | Month | 29 | Day |
Last modified on
| 2021 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021763
| Research Plan | |
|---|---|
| Registered date | File name |
| 2020/04/02 | DRCP NGT 2018.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2020/04/02 | DRCP DM 2017.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
