UMIN-CTR Clinical Trial

Basic information
Public title	Clinical effects of meal intake time intervention in patients with type 2 diabetes: a prospective observational study
Acronym	Meal intake time intervention study
Scientific Title	Clinical effects of extension of meal intake time in patients with type 2 diabetes: a prospective observational study
Scientific Title:Acronym	Meal intake time intervention study
Region	Japan

Condition
Condition	type 2 diabetes
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the clinical effect of extension of meal intake time in patients with type 2 diabetes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparing the difference in HbA1c between normal nutritional guidance and same nutritional guidance plus extension of meal intake time for dinner.
Key secondary outcomes	1: Comparing the difference in body weight and/or BMI between normal nutritional guidance and same nutritional guidance plus extension of meal intake time for dinner. 2: Comparing the difference in several factors as follow between normal nutritional guidance and same nutritional guidance plus extension of meal intake time for dinner. 1.GA 2.FPG (mg/dL) 3.systolic blood pressure (mmHg) 4.diastolic blood pressure (mmHg) 5.lipid profile 6.renal function: eGFR (ml/min/1.73m2) 7.liver function: AST, ALT, GGT 8.FIB-4 index 3: Association the change of HbA1c and several factors as follow between two groups. 1.GA 2.FPG (mg/dL) 3.systolic blood pressure (mmHg) 4.diastolic blood pressure (mmHg) 5.lipid profile 6.renal function: eGFR (ml/min/1.73m2) 7.liver function: AST, ALT, GGT 8.FIB-4 index 9.body weight (kg), BMI (kg/mm2) 10.detail of medication and number of take medicine 4: Association the change of body weight and several factors as follow between two groups. 1.GA 2.FPG (mg/dL) 3.systolic blood pressure (mmHg) 4.diastolic blood pressure (mmHg) 5.lipid profile 6.renal function: eGFR (ml/min/1.73m2) 7.liver function: AST, ALT, GGT 8.FIB-4 index 9.HbA1c (%) 10.detail of medication and number of take medicine

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Behavior,custom
Interventions/Control_1	Provide normal nutritional guidance plus instruct to double their meal intake time for dinner.
Interventions/Control_2	Provide normal nutritional guidance.
Interventions/Control_3
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	The selection criteria for the subjects are as follow. 1. Patients who have been diagnosed as type 2 diabetes. 2. Over 20 years old.
Key exclusion criteria	The exclusion criteria for the subjects are as follow. 1. Subjects with acute and/or chronic inflammation 2. Subjects with fresh cardiovascular and/or cerebrovascular diseases 3. Subjects with liver cirrhosis. 4. Subjects with severe respiratory disease or severe heart failure 5. Subjects with alcoholicsm or medicinal intoxication 6. Subjects with psychosis 7. Subjects who doctors judge as unfitness
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Takeshi Middle name Last name Matsumura
Organization	Nishinihon Hospital
Division name	Metabolic Medicine
Zip code	861-8034
Address	3-20-1 Hattanda, Higashi-ku, Kumamoto
TEL	096-380-1111
Email	takeshim@gpo.kumamoto-u.ac.jp

Public contact
Name of contact person	1st name Hongo Middle name Last name Emi
Organization	Nishinihon Hospital
Division name	Department of Nutrition
Zip code	861-8034
Address	3-20-1 Hattanda, Higashi-ku, Kumamoto
TEL	0963801111
Homepage URL
Email	hcaelb_a@yahoo.co.jp

Sponsor
Institute	Department of Metabolic Medicine, Nishinihon Hospital
Institute
Department

Funding Source
Organization	Self funding Department of Metabolic Medicine, Nishinihon Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

IRB Contact (For public release)
Organization	Nishinihon Hospital Ethics Review Committee
Address	3-20-1 Hattanda, Higashi-ku, Kumamoto
Tel	0963801111
Email	takeshim@gpo.kumamoto-u.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	西日本病院（熊本）

Other administrative information
Date of disclosure of the study information	2022 Year 02 Month 13 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	Open public recruiting
Date of protocol fixation	2022 Year 02 Month 13 Day
Date of IRB	2022 Year 01 Month 19 Day
Anticipated trial start date	2022 Year 02 Month 13 Day
Last follow-up date	2024 Year 01 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 02 Month 13 Day
Last modified on	2022 Year 02 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053504