UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000057636 |
|---|---|
| Receipt number | R000065796 |
| Scientific Title | Improve diabetes and obesity through a 6-month period for JR West |
| Date of disclosure of the study information | 2026/06/30 |
| Last modified on | 2025/04/17 11:53:58 |
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Basic information
Public title
Improve diabetes and obesity through a 6-month period for JR West
Acronym
DOJR Study
Scientific Title
Improve diabetes and obesity through a 6-month period for JR West
Scientific Title:Acronym
DOJR Study
Region
| Japan |
Condition
Condition
Type2 Diabetes, Obesity
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In the 20th century, it is known that the number of cars owned is proportional to the increase in the number of diabetic patients. The decrease in exercise is involved in increased diabetes and obesity.
This clinical study will examine whether increasing exercise will contribute to health promotion by distributing a six-month period from Nishi-Akashi to Sannomiya Station for patients with type 2 diabetes and obese patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Type 2 diabetes or obese patients who are visiting Fukuyama Healthy Clinic or Fukuyama Hospital. The following items are measured every three months.
1. Height: Weight
2. Steps per day
3. Blood pressure
4. Blood glucose: HbA1c (6 months later for non-diabetic patients)
Key secondary outcomes
1. Lipid test: cholesterol level, LDL-cholesterol, triglyceride levels
2. Liver function: AST ALT gamma-GTP
3. Renal function: BUN Cr eGFR UA Na K Cl
4. Measurement using In-Body measurement: body fat percentage, skeletal muscle index, lower limb muscle mass, phase angle
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
This clinical study will examine whether increased physical activity will contribute to improved health by distributing six-month commuter passes from Nishi-Akashi to Sannomiya Station to type 2 diabetes patients.
Interventions/Control_2
This clinical study will examine whether increased physical activity will contribute to improved health by distributing six-month commuter passes from Nishi-Akashi to Sannomiya Station to obese patients.
Interventions/Control_3
This clinical study will examine whether increased physical activity will contribute to improved health by distributing six-month commuter passes from Nishi-Akashi to Sannomiya Station to non-obese individuals.
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
| 45 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Type 2 diabetes patient group
Diabetic patients undergoing outpatient treatment, HbA1c less than 9%, non-ketosis
2. Obese patient group
BMI 25 or more, non-diabetes
3. Non-diabetic, non-obese group
BMI less than 25, non-diabetes
Key exclusion criteria
1. HbA1c 9% or more
2. Ketosis
3. BMI less than 19.5%
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | MASAO |
| Middle name | |
| Last name | NAGATA |
Organization
Fukuyama-Sukoyaka Clinic
Division name
Internal Medicine
Zip code
673-0018
Address
1-23, 3-chome, Nishiakashi Kita-machi, Akashi City, Hyogo Prefecture, Japan
TEL
078-924-0800
masao.med.nagata0122@icloud.com
Public contact
Name of contact person
| 1st name | MASAO |
| Middle name | |
| Last name | NAGATA |
Organization
Fukuyama-Sukoyaka Clinic
Division name
Internal Medicine
Zip code
673-0018
Address
1-23, 3-chome, Nishiakashi Kita-machi, Akashi City, Hyogo Prefecture, Japan
TEL
078-924-0500
Homepage URL
masao.med.nagata0122@icloud.com
Sponsor or person
Institute
FUKUYAMA HOSPITAL
Institute
Department
Personal name
Tsuyoshi Fukuyama
Funding Source
Organization
JR West
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukuyama Hospital
Address
5-55, 2-chime, suzurimachi, Akashi City, Hyogo Prefecture, Japan
Tel
078-927-1514
ijinkai@eos.ocn.ne.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
| 2026 | Year | 06 | Month | 30 | 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
| 2024 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 30 | 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 | 04 | Month | 17 | Day |
Last modified on
| 2025 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000065796
