UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058914 |
|---|---|
| Receipt number | R000067373 |
| Scientific Title | A retrospective study evaluating the effectiveness of therapeutic guidance for lifestyle-related diseases. |
| Date of disclosure of the study information | 2025/08/28 |
| Last modified on | 2025/08/27 16:56:57 |
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Basic information
Public title
A retrospective study evaluating the effectiveness of therapeutic guidance for lifestyle-related diseases.
Acronym
A retrospective study evaluating the effectiveness of therapeutic guidance for lifestyle-related diseases.
Scientific Title
A retrospective study evaluating the effectiveness of therapeutic guidance for lifestyle-related diseases.
Scientific Title:Acronym
A retrospective study evaluating the effectiveness of therapeutic guidance for lifestyle-related diseases.
Region
| Japan |
Condition
Condition
Any of the following: diabetes, hypertension, or dyslipidemia
Classification by specialty
| Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To retrospectively evaluate changes in lifestyle survey responses and clinical parameters at each of the first to third sessions of therapeutic guidance provided to patients with lifestyle-related diseases (diabetes, hypertension, or dyslipidemia), and to clarify how such guidance influences patients' lifestyle habits and health status.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the following parameters before and after therapeutic guidance among all participants: body weight, BMI, blood pressure (systolic and diastolic), HbA1c, total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol."
Key secondary outcomes
Changes in the following parameters before and after therapeutic guidance, stratified by patient group: HbA1c, body weight, and BMI in patients with diabetes; blood pressure in patients with hypertension; and body weight, BMI, total cholesterol, triglycerides, HDL cholesterol, and LDL cholesterol in patients with dyslipidemia. Additionally, changes in responses to lifestyle survey items compared to pre-guidance levels.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
All data collected at our institution between June 1, 2024, and May 31, 2025.
Key exclusion criteria
Individuals who requested to be excluded from the study through the opt-out process regarding the study's s purpose and content
Target sample size
87
Research contact person
Name of lead principal investigator
| 1st name | Susumu |
| Middle name | |
| Last name | Kimura |
Organization
Kimura Naika Clinic
Division name
N/A
Zip code
629-2404
Address
643-7 Ushirono Yosano-cho Yosa-gun Kyoto
TEL
0772-43-2134
kimuranaika_clinic_kyoto@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Susumu |
| Middle name | |
| Last name | Kimura |
Organization
Kimura Naika Clinic
Division name
N/A
Zip code
629-2404
Address
643-7 Ushirono Yosano-cho Yosa-gun Kyoto
TEL
0772-43-2134
Homepage URL
kimuranaika_clinic_kyoto@yahoo.co.jp
Sponsor or person
Institute
Kimura Naika Clinic
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The clinical research ethical review board of Shido. Inc.
Address
614, 3-13-2 Kameari, Katsushika-ku, Tokyo
Tel
03-4500-5075
info@shido.co.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
| 2025 | Year | 08 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 08 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data collected at our institution between June 1, 2024, and May 31, 2025 will be compiled into an analytical dataset. The dataset finalized by the data manager will be analyzed by the statistical analyst.
Management information
Registered date
| 2025 | Year | 08 | Month | 28 | Day |
Last modified on
| 2025 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067373
