UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063485 |
|---|---|
| Receipt number | R000072591 |
| Scientific Title | A Prospective Intervention Study Aimed at Achieving Remission Through Early Lifestyle Intervention in Participants Newly Diagnosed with Diabetes or Prediabetes During Health Screenings |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/11/01 01:29:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Study on the Remission of Diabetes and Prediabetes Through Early Lifestyle Intervention for Individuals Diagnosed with Diabetes or Prediabetes During Health Screenings
Acronym
SCREEN-DMREM Study
Screening-Based Early Intervention for Diabetes Mellitus Remission
Scientific Title
A Prospective Intervention Study Aimed at Achieving Remission Through Early Lifestyle Intervention in Participants Newly Diagnosed with Diabetes or Prediabetes During Health Screenings
Scientific Title:Acronym
SCREEN-DMREM Study
Screening-Based Early Intervention for Diabetes Mellitus Remission
Region
| Japan |
Condition
Condition
Individuals newly identified with diabetes or prediabetes at health screening
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess diabetes remission at 12 months after a 12-month lifestyle intervention and remission maintenance or relapse during a further 24 months of follow-up. Improvement in prediabetes will be evaluated separately (proposed amendment).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of participants with diabetes achieving remission at 12 months, defined as HbA1c <6.5% maintained for at least 3 months without glucose-lowering medication
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Dietary intervention targeting 1,200-1,500 kcal/day and approximately 130 g/day or less of carbohydrates; at least 150 minutes/week of aerobic activity; monthly outpatient follow-up.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Individuals aged 20 years or older and younger than 75 years.
2. Individuals identified as having diabetic-range hyperglycemia or prediabetes during a health checkup.
3. Individuals diagnosed with type 2 diabetes or prediabetes following further evaluation at our hospital.
4. Both individuals who seek medical care promptly after the health checkup and those who have not previously sought medical care despite abnormal findings and subsequently visit our hospital for the first time are eligible.
5. Individuals who provide written informed consent to participate in the study.
Key exclusion criteria
Clear insulin dependence (e.g., low C-peptide), severe liver disease, renal failure, malignancy, or investigator judgment of ineligibility.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Eita |
| Middle name | |
| Last name | Nishimori |
Organization
Asama General Hospital
Division name
Diabetes Medicine
Zip code
3858558
Address
1862-1, Iwamurada, Saku Nagano
TEL
0267672295
westwoods0616@gmail.com
Public contact
Name of contact person
| 1st name | Eita |
| Middle name | |
| Last name | Nishimori |
Organization
Asama General Hospital
Division name
Diabetes Medicine
Zip code
3858558
Address
1862-1, Iwamurada, Saku Nagano
TEL
0267672295
Homepage URL
westwoods0616@gmail.com
Sponsor or person
Institute
Asama General Hospital
Institute
Department
Personal name
Eita Nishimori
Funding Source
Organization
Asama General Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asama General Hospital
Address
1862-1, Iwamurada, Saku Nagano
Tel
0267672295
asama-soumu@city.saku.nagano.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 | 11 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 09 | 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
| 2026 | Year | 11 | Month | 01 | Day |
Last modified on
| 2026 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072591
