UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051269 |
|---|---|
| Receipt number | R000058422 |
| Scientific Title | Elucidation of risk factors for Cognitive Decline/ Frailty in Diabetes and Obesity-To establish effective early detection and prognosis prediction methods- |
| Date of disclosure of the study information | 2023/07/01 |
| Last modified on | 2023/06/06 13:45:29 |
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Basic information
Public title
THe elucidation of risk factors for Cognitive Decline/ Frailty in Diabetes and Obesity-To establish effective early detection and prognosis prediction methods-
Acronym
JOMS/J-DOS3
Scientific Title
Elucidation of risk factors for Cognitive Decline/ Frailty in Diabetes and Obesity-To establish effective early detection and prognosis prediction methods-
Scientific Title:Acronym
JOMS/J-DOS3
Region
| Japan |
Condition
Condition
type2 diabetes mellitus, obesity
Classification by specialty
| Medicine in general | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to elucidate the actual conditions and risk factors of MCI and frailty (cognitive frailty), which are the biggest factors requiring nursing care and dementia in patients with type 2 diabetes and obesity, and to establish effective early diagnosis indicators and early assessment panels by integrating existing indicators and blood markers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Cognitive function test: MMSE(MCI: 24-27 points)and Simple Frail Questionnaire (Frail: 3 points or more).We will check them every 1 year for 5years.
Key secondary outcomes
1)Cognitive function tests:
a)Cognitive function test: MMSE(Dementia:23 points or less, MCI:24-27 points)
b)Imaging tests: brain MRI(T1-weighted, T2-weighted, FLAIR, diffusion-weighted, T2star, MRA)
2)Frailty
a)Simple Frail Questionnaire (Frail: 3 points or more, Pre-Frail: 2 points)
b)Ministry of Health, Labour and Welfare: Basic Checklist for Frailty
3)Event occurrence
a)Combined cerebrovascular events:cardiovascular death and nonfatal acute myocardial infarction requiring hospitalization, nonfatal stroke, acute coronary syndrome, aortic and peripheral artery disease, heart failure, angioplasty for coronary artery, aorta and peripheral artery.
b)All-cause mortality
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients shall meet all of the following criteria
1)Disease and diagnosis: Patients who meet one or both of the following criteria
Patients diagnosed as type 2 diabetes mellitus.
Obesity:BMI 25 kg/m2 and upwards(according to the guidelines of the Japan Society for the Study of Obesity)
2)Age: Patients who are 40 years of age or older at the time of consent
3)Gender:Any gender
4)Patients attending outpatient clinics or hospitalized in departments related to lifestyle-related diseases(internal medicine, diabetes, endocrinology and metabolism, general internal medicine, cardiovascular medicine, etc.)at National Hospital Organization facilities nationwide
5)Documented consent of the subject or the surrogate: Patients who have given written consent of their own free will or that of their surrogate.
Key exclusion criteria
1) Patients with secondary obesity(adrenal gland disease, etc.)
2) Patients with severe hepatic dysfunction or cirrhosis
3) Patients with serious renal dysfunction (serum creatinine level:3.0 mg/dl or higher)
4) Female patients who are pregnant or may become pregnant
5) Patients who are judged to be inappropriate to participate in this study by the principal investigator and research coordinators.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Asahara |
Organization
National Hospital Organization, Kyoto Medical Center
Division name
Department of Endocrinology, Metabolism and Hypertension Research, Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL
075-641-9161
nsatoh@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Asahara |
Organization
National Hospital Organization, Kyoto Medical Center
Division name
Department of Endocrinology, Metabolism and Hypertension Research, Clinical Research Institute
Zip code
612-8555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL
075-641-9161
Homepage URL
nsatoh@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Clinical Research Institute,National Hospital Organization, Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Central Ethics Review Committee for Clinical Research, Office of Clinical Research Promotion, Department of Clinical Research Management, National Hospital Organization, Comprehensive Research Center
Address
2-5-21 Higashigaoka, Meguro-ku, Tokyo 152-8621
Tel
03-5712-5075
700-kenkyu@mail.hosp.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R4-NHO(endocrine-kidney)-01
Org. issuing International ID_1
National Hospital Organization
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | 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
| 2022 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Main Observation Items
1.Body composition: height, weight, BMI
2.Glucose metabolism: plasma glucose level, HbA1c
3.Dementia-related blood markers;
Blood sTREM2, Blood t-tau/p-tau,AB42/40
4.Skeletal muscle related markers;
Myokines (myostatin, irisin, BDNF, etc.)
Management information
Registered date
| 2023 | Year | 06 | Month | 06 | Day |
Last modified on
| 2023 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058422
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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