UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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-
Title of the study (Brief title)	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	Saeko Imai
Organization	Kyoto Women's University
Division name	Department of Food and nutrition, Faculty of Home Economics
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	Saeko Imai
Organization	Kyoto Women's University
Division name	Department of Food and nutrition, Faculty of Home Economics
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's University
Institute
Department

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

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

Progress
Recruitment status	Main results already published
Date of protocol fixation	2014 Year 09 Month 01 Day
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

Related information
URL releasing protocol	http://www.sciencedirect.com/science/article/pii/S016882271730133X
Publication of results	Published
URL releasing results	http://www.sciencedirect.com/science/article/pii/S016882271730133X
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.
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/icdr_e/ctr_view.cgi?recptno=R000017579