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 |
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
A comparative trial of healthy gut microbiota-based and conventional diet tool for patients with Type 2 diabetes
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
A comparative trial of healthy gut microbiota-based and conventional diet tool for patients with Type 2 diabetes
Japan |
Type 2 diabetes mellitus
Endocrinology and Metabolism | Nursing |
Others
NO
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.
Efficacy
HbA1c (after 6 months)
(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
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
No need to know
2
Educational,Counseling,Training
Behavior,custom |
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.)
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.)
Not applicable |
Not applicable |
Male and Female
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)
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
100
1st name | Takatoshi |
Middle name | |
Last name | Kato |
Hokkaido University
Office of Diversity, Equity, and Inclusion
060-0812
Kita 12, Nishi 7, Kita-ku, Sapporo Hokkaido 060-0812, JAPAN
011-706-3625
kato@dei.hokudai.ac.jp
1st name | Takatoshi |
Middle name | |
Last name | Kato |
Hokkaido University
Office of Diversity, Equity, and Inclusion
060-0812
Kita 12, Nishi 7, Kita-ku, Sapporo Hokkaido 060-0812, JAPAN
050-3717-9209
kato@dei.hokudai.ac.jp
Hokkaido University
Takatoshi Kato
Japan Society for the Promotion of Science
Other
JAPAN
Sapporo University of Health Sciences Research Ethics Committee
4-2-1-15 Nakanuma-nishi, Higashi-ku, Sapporo, Hokkaido 007-0894, JAPAN
011-792-3350
somu@sapporo-hokeniryou-u.ac.jp
NO
2023 | Year | 03 | Month | 10 | Day |
Unpublished
No longer recruiting
2023 | Year | 01 | Month | 13 | Day |
2023 | Year | 01 | Month | 19 | Day |
2023 | Year | 03 | Month | 11 | Day |
2024 | Year | 10 | Month | 11 | Day |
2026 | Year | 03 | Month | 11 | Day |
2026 | Year | 03 | Month | 11 | Day |
2026 | Year | 03 | Month | 11 | Day |
2023 | Year | 03 | Month | 10 | Day |
2025 | Year | 03 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057573