UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009465 |
|---|---|
| Receipt number | R000011065 |
| Scientific Title | Cross-over study of eating snacks at different timing on glycemic excursions assessed by continuous glucose monitoring system (CGMS) in patients with and without type 2 diabetes |
| Date of disclosure of the study information | 2012/12/03 |
| Last modified on | 2019/06/10 14:09:09 |
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Basic information
Public title
Cross-over study of eating snacks at different timing on glycemic excursions assessed by continuous glucose monitoring system (CGMS) in patients with and without type 2 diabetes
Acronym
Cross-over study of eating snacks at different timing on glycemic excursions assessed by CGMS
Scientific Title
Cross-over study of eating snacks at different timing on glycemic excursions assessed by continuous glucose monitoring system (CGMS) in patients with and without type 2 diabetes
Scientific Title:Acronym
Cross-over study of eating snacks at different timing on glycemic excursions assessed by CGMS
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the study is to determine whether the timing of eating snacks at varying timing differ glycemic excursions in people with and without type 2 diabetes.
Basic objectives2
Others
Basic objectives -Others
The objective of the study is to determine whether the timing of eating snacks at varying timing differ glycemic excursions in outpatients with and without type 2 diabetes.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Daily glucose excursions; mean glucose, glucose standard diviaion, mean amplitude of glycemic excursions (MAGE), largest amplitude of glycemic excursions (LAGE).
Key secondary outcomes
Postaprandial plasma glucose, incremental area under the curve (IAUC)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
All participants are assigned to perform CGM for 6 days by eating snacks after lunch or dinner or between lunch and dinner in a randomized cross-over design. At 12:00 of the first day, each participant wears a CGM at clinic, and the 2nd to the 4th day they consume the test meals at 7:00, 12:00, and 19:00 at home, and at noon of the 6th day a CGM is removed at clinic. At least four daily SMBG measurements are obtained with a gluco-meter and enter into the CGM for calibration. CGM data are downloaded using the software and saved electrically. All subjects receive dietary instructions from the dietitians. All participants are not permitted eating besides test meals, alcohol consumption, and intensive physical activities during the study period. The test meals consist of rice/bread, meat/fish, 500 g of vegetables, milk and energy ratios are 58 % from carbohydrates, 17% from proteins and 25% from fat. The subjects eat the first dish of vegetables for 5 min, then the main dishes (frozen foods) for 5 min, and consume rice or bread for 5 min with a 10-min interval between vegetables and carbohydrates in each meal.
Snacks are consumed in the different time on 3 days (2nd to 4th day). All participants consume the snack after lunch.
Interventions/Control_2
All participants consume the identical test meals and consume the snack between lunch and dinner.
Interventions/Control_3
All participants wihout type 2 diabetes consume the identical test meals and consume the snack after dinner.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Consecutive adult patients with type 2 diabetes are recruited among outpatients regularly attending diabetes clinic, Kajiyama Clinic located in Kyoto, Japan. All patients had type 2 diabetes as defined by Word Health Organization criteria, and HbA1c less than 9%. Healthy adults without type 2 diabetes are recruited.
Key exclusion criteria
Patients who have liver disease, any life-threatening disease, severe complications of diabetes, nephropathy, history of cerebral or myocardial infarction, and treatment with steroidal anti-inflammatory drugs, and drug or alcohol abuse are excluded.
Target sample size
30
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, Faculty of Home Economics
Zip code
605-8501
Address
35, Imakumano, Kitahiyoshi-cho, Higashiyama-ku, Kyoto 605-8501
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, Faculty of Home Economics
Zip code
605-8501
Address
35, Imakumano, Kitahiyoshi-cho, Higashiyama-ku, Kyoto 605-8501
TEL
075-531-7128
Homepage URL
imais@kyoto-wu.ac.jp
Sponsor or person
Institute
Department of Food and Nutrition, Kyoto Women's University
Institute
Department
Personal name
Funding Source
Organization
Grant-in Aid for Scientific Research from the Ministry of Education, Science, and Culuture
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)
Kajiyama Clinic, Kyoto, Japan
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
| 2012 | Year | 12 | Month | 03 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_view_reg.cgi?recptno=R000011065
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/abs/pii/S1262363618301228?via%3Dihub
Number of participants that the trial has enrolled
39
Results
This study demonstrated that consuming snacks at post-dinner affects the postprandial glucose levels even in the following post-breakfast. On the other hand, consuming snacks at mid-afternoon could be a successful strategy for reduction of glucose excursions in healthy women. Consuming snacks well separated from lunch may be an effective way to suppress postprandial glucose levels in both people with and without type 2 diabetes.
Results date posted
| 2019 | Year | 06 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 09 | Month | 01 | Day |
Baseline Characteristics
Seventeen people with type 2 diabetes: age 67.4 years, BMI 23.5, HbA1c 7.2%. Seventeen healthy women: 21.2 years, BMI 20.7, HbA1c 5.1% (mean).
Participant flow
Twenty volunteers with type 2 diabetes were enrolled in the study, but 3 were excluded due to discontinuation of the study protocol. Ninteen healthy volunteers enrolled in the study, but 2 were excluded becaause of non-adherence to the study protocol.
Adverse events
none
Outcome measures
mean blood glucose, standard deviation of blood glucose, mean amplitude of glycemic excursions, incremental area under the glucose curve
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2012 | Year | 11 | Month | 20 | Day |
Date of IRB
| 2011 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 02 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 03 | Day |
Last modified on
| 2019 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011065
