UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015108 |
|---|---|
| Receipt number | R000017579 |
| Scientific Title | Effect of consuming divided dinner on glucose fluctuations in patients with type 2 diabetes and subjects with normal glucose tolerance -Randomized cross-over study by using CGM- |
| Date of disclosure of the study information | 2014/09/10 |
| Last modified on | 2017/06/07 13:21:21 |
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Basic information
Public title
Effect of consuming divided dinner on glucose fluctuations in patients with type 2 diabetes and subjects with normal glucose tolerance
-Randomized cross-over study by using CGM-
Acronym
The study of diabetic diet for reducing glucose fluctuations in patients with diabetes
Scientific Title
Effect of consuming divided dinner on glucose fluctuations in patients with type 2 diabetes and subjects with normal glucose tolerance
-Randomized cross-over study by using CGM-
Scientific Title:Acronym
The study of diabetic diet for reducing glucose fluctuations in patients with diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Consuming late dinner is reported to increase fat, blood glucose, and insulin secretion, and as results, it increases the risk of obese, hyperlipidemia, and diabetes. We evaluate whether eating late dinner or consuming divided dinner could change the postprandial glucose levels and daily glucose fluctuations assessed by continuous glucose monitoring system (CGM) in Japanese subjects with type 2 diabetes mellitus (T2DM) and normal glucose tolerance (NGT).
Basic objectives2
Others
Basic objectives -Others
This is a randomized cross-over study of consuming late dinner and divided dinner on blood glucose, glucose fluctuations, incremental glucose peak, incremental glucose peak (IGP), and area under the glucose curve (AUC) by using continuous glucose monitoring system (CGM) in subjects with T2DM and NGT.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Daily glucose excursions, mean glucose, glucose standard diviation, mean amplitude of glycemic excursions (MAGE) by CGM
Key secondary outcomes
Postprandial plasma glucose, incremental area under the glucose curve, incremental glucose peak
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
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
First, at 12:00 of the 1st day, each participant wears a CGM (iPro2, Medtronic) at the clinic, and consumes the test meals at 8:00, 13:00 and 21:00 at home on the 2nd day.The subjects consume the first dish of vegetables for 5 min, then the main dishes for 5 min, and rice or bread for 5 min of the test meals.
Interventions/Control_2
Subjects consume the same test meals at 8:00, 13:00, and 18:00 on the 3nd day.
Interventions/Control_3
Subjects consume the test meals at 8:00, 13:00, and 18:00 (vegetables and rice), and 21:00 (vegetables and meat) on the 4th day. Half of the subjects consume reverse way on the 2nd and the 4th day. On the 5th day a CGM is removed at the clinic.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Consecutive adult patients with type 2 diabetes are recruited among outpatients regularly attending Kajiyama Clinic located in Kyoto, Japan. All patients are type 2 diabetes as defined by WHO criteria, and HbA1c less than 9.0%.
Healthy adults are recruited among Osaka Prefecture University and others without diabetes.
Key exclusion criteria
Subjects who have liver disease, severe complications of diabetes, nephropathy, storoke, history of cerebral myocardial infarction, and treatment with steroidal anti-inflammatory drugs, and drug or alcohol abuse, mental illness are excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Saeko Imai |
Organization
Kyoto Women's University
Division name
Department of Food and nutrition, Faculty of Home Economics
Zip code
Address
35, Kitahiyoshi, Imakumano, Higashiyama-ku, Kyoto, 615-8501
TEL
+81-75-531-7128
imais@kyoto-wu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Saeko Imai |
Organization
Kyoto Women's University
Division name
Department of Food and nutrition, Faculty of Home Economics
Zip code
Address
35, Kitahiyoshi, Imakumano, Higashiyama-ku, Kyoto, 615-8501
TEL
+81-75-531-7128
Homepage URL
imais@kyoto-wu.ac.jp
Sponsor or person
Institute
Kyoto Women's University
Institute
Department
Personal name
Funding Source
Organization
Kyoto Women's University
Organization
Division
Category of Funding Organization
Other
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
Address
Tel
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）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | Month | 10 | Day |
Related information
URL releasing protocol
http://www.sciencedirect.com/science/article/pii/S016882271730133X
Publication of results
Published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S016882271730133X
Number of participants that the trial has enrolled
Results
Our study is the first to show that in patients with type 2 diabetes, (1) consuming a late-night-dinner led to postprandial hyperglycemia, and (2) this postprandial hyperglycemia after the late-night-dinner can be ameliorated by consuming a divided dinner. The strategy of consuming a divided dinner might provide a crucial contribution to the prevention of diabetic complications in patients with type 2 diabetes who cannot avoid eating late at night.
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
Main results already published
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 10 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 10 | Day |
Date trial data considered complete
| 2016 | Year | 09 | Month | 13 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 09 | Month | 10 | Day |
Last modified on
| 2017 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017579
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