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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000015108
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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&#39;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
Email imais@kyoto-wu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Saeko Imai
Organization Kyoto Women&#39;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
Email imais@kyoto-wu.ac.jp

Sponsor
Institute Kyoto Women&#39;s University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Kyoto Women&#39;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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017579


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