UMIN-CTR Clinical Trial

Basic information
Public title	A study evaluating the effect of notification of postprandial hyperglycemia and supporting counter measures on the habits of eating and exercising, and on the parameters of glucose metabolism.
Acronym	A study evaluating the effect of notification of postprandial hyperglycemia and supporting counter measures on the habits of eating and exercising, and on the parameters of glucose metabolism.
Scientific Title	A study evaluating the effect of notification of postprandial hyperglycemia and supporting counter measures on the habits of eating and exercising, and on the parameters of glucose metabolism.
Scientific Title:Acronym	A study evaluating the effect of notification of postprandial hyperglycemia and supporting counter measures on the habits of eating and exercising, and on the parameters of glucose metabolism.
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective is to evaluate the effect of notification of postprandial hyperglycemia and supporting counter measures on the habits of eating and exercising, and on the parameters of glucose metabolism.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HbA1c
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	Subjects follow the instructions of life-style work as counter measures, while they record their daily implementation for 3-4 months.
Interventions/Control_2	Subjects take notification of possible postprandial hyperglycemia. Then, they follow the instructions of life-style work as counter measures, while they record their daily implementation for 3-4 months.
Interventions/Control_3	Subjects take notification of possible postprandial hyperglycemia. Then, they follow the instructions of life-style work as counter measures, while they record their daily implementation for 3-4 months. During the intervention term, they are encouraged to execute the work.
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Healthy male and female subjects whose ages are 20 <= years old <65. (2)Subjects who agree with the given description and express informed consent via Web or written documents. (3)Subjects who underwent an annual medical check-up in 2022. (4)Subjects whose fasting blood glucose (FPG) is equal to or more than 100 mg/dL, and whose FPG is lower than 126 mg/dL. (5)Subjects whose predicted blood glucose level during the 75g OGTT is equivalent to or more than 126 mg/dL at 120 min., or whose predicted Matsuda-index is lower than 4.97, based on the algorithm calculation. (6)Subjects who can use the smartphone application.
Key exclusion criteria	(1)Systolic pressure <90 mmHg (2)Pregnant or lactating. (3)Who donated over 200ml blood components or whole blood within the past 4 weeks prior to the current study. (4)Male who donated over 400ml whole blood within the past 12 weeks prior to the current study. (5)Female who donated over 400ml whole blood within the past 16 weeks prior to the current study. (6)Male whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added. (7)Female whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added. (8)Who are participating in other clinical studies, or who finished clinical study within the last 4 weeks. (9)Subjects a)with disease on heart, liver, kidney or other organs complications. b)with a previous history of disease on circulatory organs. c)who are contracting diabetes. (10)Who have possibility to be diagnosed as diabetes; whose HbA1c is equal to or more than 6.5 % or have past medical history of diabetes. (11)Who have increased the frequency of hard physical activity 1 day or more after a medical check-up conducted in 2022, or who have those constant habits 3 days or more per week. (12)Who restrict diets including carbohydrate. (13)Who must follow the specific health guidance. (14)With a previous history of feeling sick after blood sampling. (15)Who have difficulty in blood sampling from peripheral vein. (16)Who drink alcohol a lot. (17)Who have irregular eating patterns. (18)Who work irregular shifts or at midnight. (19)Whose BMI is less than 18.5 or equal to or more than 30.0 kg/m2. (20)Who are contracting alcohol hypersensitivity. (21)Who are judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size	75

Research contact person
Name of lead principal investigator	1st name Noriyuki Middle name Last name Kanzaki
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
Zip code	619-0238
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0666
Email	Noriyuki_Kanzaki@suntory.co.jp

Public contact
Name of contact person	1st name Shinya Middle name Last name Fukizawa
Organization	Suntory Global Innovation Center Ltd.
Division name	Research Institute
Zip code	619-0238
Address	8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL	050-3182-0595
Homepage URL
Email	Shinya_Fukizawa@suntory.co.jp

Sponsor
Institute	Suntory Global Innovation Center Ltd.
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address	Higashitenma building 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel	06-6135-5200
Email	info@miura-cl.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

Other administrative information
Date of disclosure of the study information	2022 Year 10 Month 06 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	Preinitiation
Date of protocol fixation	2022 Year 09 Month 29 Day
Date of IRB	2022 Year 09 Month 29 Day
Anticipated trial start date	2022 Year 10 Month 14 Day
Last follow-up date	2023 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 10 Month 04 Day
Last modified on	2022 Year 10 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055957