UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060145 |
|---|---|
| Receipt number | R000055551 |
| Scientific Title | Effects of individualized dietary advice using a dietary questionnaire for adults with type 2 diabetes in a small medical institution: A multicenter randomized clinical trial |
| Date of disclosure of the study information | 2025/12/20 |
| Last modified on | 2025/12/20 13:18:58 |
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Basic information
Public title
Effects of individualized dietary advice using a dietary questionnaire for adults with type 2 diabetes in a small medical institution: A multicenter randomized clinical trial
Acronym
Effects of individualized dietary advice using a dietary questionnaire for adults with type 2 diabetes in a small medical institution: A multicenter randomized clinical trial
Scientific Title
Effects of individualized dietary advice using a dietary questionnaire for adults with type 2 diabetes in a small medical institution: A multicenter randomized clinical trial
Scientific Title:Acronym
Effects of individualized dietary advice using a dietary questionnaire for adults with type 2 diabetes in a small medical institution: A multicenter randomized clinical trial
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A randomized controlled trial will examine the effects of individualized dietary advice based on food and nutrient intakes using dietary questionnaire for adults with type 2 diabetes in small medical institutions (hospitals or clinics with 99 or fewer general beds).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mean change in HbA1c from baseline at 6 months
Key secondary outcomes
Changes in weight, serum triglyceride, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and intakes of foods and nutrients
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
The intervention group will receive dietary advice using the BDHQ individual feedback sheet from their physician approximately two to three times in six months, depending on the frequency of outpatient visits to their physician.
Interventions/Control_2
The control group will not receive the BDHQ feedback sheets, and the sheets will not be disclosed to either the physician or the patient. Patients receive dietary advice to what the physician notices during the interview.
Neither group will receive dietary advice from a dietitian during the intervention and follow-up periods.
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
Adults diagnosed with type 2 diabetes.
They must have received and understood a full explanation of the purpose and contents of this study and must have given their free and voluntary consent in writing.
Key exclusion criteria
Pregnant women, those with severe renal dysfunction (overt proteinuria or end-stage renal failure), and those who withdraw their consent to participate during the study period.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Omura |
Organization
The Jikei University School of Medicine, Tokyo, Japan
Division name
Division of Diabetes, Metabolism, and Endocrinology, Department of Internal Medicine,
Zip code
105-0003
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
yukaomura@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Omura |
Organization
The Jikei University School of Medicine, Tokyo, Japan
Division name
Division of Diabetes, Metabolism, and Endocrinology, Department of Internal Medicine,
Zip code
105-0003
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
03-3433-1111
Homepage URL
yukaomura@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine, Tokyo, Japan
Institute
Department
Personal name
Funding Source
Organization
The Jikei University School of Medicine, Tokyo, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University School of Medicine, Tokyo, Japan
Address
3-25-8 Nishishimbashi, Minato-ku, Tokyo 105-8461, Japan
Tel
03-3433-1111
jikei@esct.bvits.com
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
| 2025 | Year | 12 | Month | 20 | Day |
Related information
URL releasing protocol
https://jikei.bvits.com/rinri/Apply/show.aspx?TYPE=3&ID=33648
Publication of results
Unpublished
Result
URL related to results and publications
https://jikei.bvits.com/rinri/Apply/show.aspx?TYPE=3&ID=33648
Number of participants that the trial has enrolled
81
Results
A total of 81 Japanese adults with type 2 diabetes from six local clinics were randomized into the PN group (n=41) or the control group (n=40).
At baseline, the mean HbA1c was 7.6% (60 mmol/L) for the PN group and 7.3% (56 mmol/L) for the control group, with no statistically significant difference. After 6 months, the mean change in HbA1c was -0.36% for the PN group and -0.02% for the control group. The mean difference in HbA1c change between the two groups was -0.33 (95% CI: -0.71, -0.02).
Results date posted
| 2025 | Year | 12 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
At baseline, the mean HbA1c was 7.6% (60 mmol/L) for the PN group and 7.3% (56 mmol/L) for the control group, with no statistically significant difference.
Participant flow
A total of 81 Japanese adults with type 2 diabetes from six local clinics were randomized into the PN group (n=41) or the control group (n=40)
Adverse events
No adverse events related to the intervention were reported during the study period.
Outcome measures
After 6 months, the mean change in HbA1c was -0.36% for the PN group and -0.02% for the control group. The mean difference in HbA1c change between the two groups was -0.33 (95% CI: -0.71, -0.02).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 20 | Day |
Last modified on
| 2025 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055551
