UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046893 |
|---|---|
| Receipt number | R000053504 |
| Scientific Title | Clinical effects of extension of meal intake time in patients with type 2 diabetes: a prospective observational study |
| Date of disclosure of the study information | 2022/02/13 |
| Last modified on | 2022/02/13 12:33:18 |
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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
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
hcaelb_a@yahoo.co.jp
Sponsor or person
Institute
Department of Metabolic Medicine, Nishinihon Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053504
