UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050560 |
|---|---|
| Receipt number | R000057573 |
| Scientific Title | The efficacy of a healthy gut microbiome-based diet tool versus a conventional diet tool for patients with Type 2 diabetes : A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial |
| Date of disclosure of the study information | 2023/03/10 |
| Last modified on | 2025/03/28 10:35:30 |
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Basic information
Public title
The efficacy of a healthy gut microbiome-based diet tool versus a conventional diet tool for patients with Type 2 diabetes : A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial
Acronym
A comparative trial of healthy gut microbiota-based and conventional diet tool for patients with Type 2 diabetes
Scientific Title
The efficacy of a healthy gut microbiome-based diet tool versus a conventional diet tool for patients with Type 2 diabetes : A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial
Scientific Title:Acronym
A comparative trial of healthy gut microbiota-based and conventional diet tool for patients with Type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop a "diet therapy tool" for patients with type 2 diabetes, which is explored from the analysis of healthy gut microbiota.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HbA1c (after 6 months)
Key secondary outcomes
(after 1,3,6,12 months)
1)Diet
2)HbA1c
3)Diabetes Mellitus Dietary Self Efficacy Scale : DMDSES
4)Diabetes treatment satisfaction questionnaire : DTSQ
5)Scale of Dietary Distress in Patients with Type 2 Diabetes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Diet therapy tool based on healthy gut microbiota (Dietary menu book)
(If the subject reviewed the content of this document, and if the attending physician reviewed, it may be possible to identify which group the subject belongs to. Because this study is a double-blind study designed to prevent physicians from deciding between intervention and placebo groups, details of this tool cannot be disclosed on this from until the study is completed.)
Interventions/Control_2
Conventional diet therapy tool (Dietary menu book) (placebo tool)
(If the subject reviewed the content of this document, and if the attending physician reviewed, it may be possible to identify which group the subject belongs to. Because this study is a double-blind study designed to prevent physicians from deciding between intervention and placebo groups, details of this tool cannot be disclosed on this from until the study is completed.)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with type 2 diabetes with an HbA1c value of 7.0% or more and 8.9% or less at the start of this survey
(However, if the number of applicants cannot be secured, the HbA1c value shall be 6.5% or more and 8.9% or less.)
2)
Key exclusion criteria
1)Patients with nephropathy-specific dietary restrictions of protein and potassium
(However, if the attending physician approves, it is possible to conduct this research.)
2)Patients who find it difficult to conduct questionnaire surveys due to dementia, mental illness, etc
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kato |
Organization
Hokkaido University
Division name
Office of Diversity, Equity, and Inclusion
Zip code
060-0812
Address
Kita 12, Nishi 7, Kita-ku, Sapporo Hokkaido 060-0812, JAPAN
TEL
011-706-3625
kato@dei.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Kato |
Organization
Hokkaido University
Division name
Office of Diversity, Equity, and Inclusion
Zip code
060-0812
Address
Kita 12, Nishi 7, Kita-ku, Sapporo Hokkaido 060-0812, JAPAN
TEL
050-3717-9209
Homepage URL
kato@dei.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Takatoshi Kato
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo University of Health Sciences Research Ethics Committee
Address
4-2-1-15 Nakanuma-nishi, Higashi-ku, Sapporo, Hokkaido 007-0894, JAPAN
Tel
011-792-3350
somu@sapporo-hokeniryou-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 11 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 11 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 11 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 10 | Day |
Last modified on
| 2025 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057573
