UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000048032 |
|---|---|
| Receipt number | R000054736 |
| Scientific Title | Development of Novel Predictive Indicators and Therapeutic Strategies for Vascular Disease and Dementia with Obesity and Diabetes by Focusing on the Dementia-Related Factor･sTREM2. |
| Date of disclosure of the study information | 2022/06/14 |
| Last modified on | 2022/06/11 07:44:49 |
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Basic information
Public title
Development of Novel Predictive Indicators and Therapeutic Strategies for Vascular Disease and Dementia with Obesity and Diabetes by Focusing on the Dementia-Related Factor･sTREM2.
Acronym
DrD biomarker study
Scientific Title
Development of Novel Predictive Indicators and Therapeutic Strategies for Vascular Disease and Dementia with Obesity and Diabetes by Focusing on the Dementia-Related Factor･sTREM2.
Scientific Title:Acronym
Diabetes-related dementia biomarker study
Region
| Japan |
Condition
Condition
1. Dementia
2. Mild Cognitive Impairment
3. diabetes mellitus
4. Obesity
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Neurology |
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between dementia-related indicators such as sTREM2 in blood levels of sTREM2 and cognitive function in patients with dementia and mild cognitive impairment attending the Kyoto Dementia Center and Department of Neurology, and to clarify whether sTREM2 can be a preventive indicator for the onset of dementia.
Basic objectives2
Others
Basic objectives -Others
To examine the association between dementia-related indicators such as sTREM2 in blood and cognitive function in patients with dementia and mild cognitive impairment attending the Kyoto Dementia Center and Department of Neurology, with or without the presence of obesity and diabetes, and to clarify the characteristics and predictive indicators of diabetic dementia.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
･MMSE(Mini-Mental State Examination)
Key secondary outcomes
･History of dementia (if dementia present, number of years since diagnosis)
･FAB(Frontal Assessment Battery)
･Diagnostic Imaging: Brain MRI
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Lower age limit: 20 years old
2. Gender: male and female
3. Persons who can obtain the consent of the person in question or a witness (substitute)
4. A person who belongs to any of the following 1) to 2)
1) Those who are inpatients or outpatients of Kyoto Medical Center for Diabetes
2) Those who are inpatients or outpatients of Kyoto Dementia Center Clinic, outpatient clinic for memory loss and diabetes.
Key exclusion criteria
1. Female examinees who are pregnant
2. Examinees judged by the principal doctor to be inappropriate for this study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Asahara |
Organization
Kyoto medical center
Division name
Department of Endocrinology, Metabolism and Hypertension Research, Clinical Research Institute
Zip code
612-8555
Address
1-1 Mukaihata-cho, Fukakusa, 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
Kyoto medical center
Division name
Department of Endocrinology, Metabolism and Hypertension Research, Clinical Research Institute
Zip code
612-8555
Address
1-1 Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto
TEL
075-641-9161
Homepage URL
nsatoh@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Center of Neurological and Cerebrovascular Diseases, Koseikai Takeda Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center of Neurological and Cerebrovascular Diseases, Koseikai Takeda Hospital
Address
36-35 Ujisatosiri, Uji-shi, Kyoto
Tel
0774-25-2577
nsatoh@kuhp.kyoto-u.ac.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
| 2022 | Year | 06 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Assessment Item: Cognitive function test
1.History of dementia (if dementia present, number of years since diagnosis)
2.MMSE(Mini-Mental State Examination)
3.FAB(Frontal Assessment Battery)
4.Diagnostic Imaging: Brain MRI
Observation items:
1.sTREM2(soluble Triggering receptor expressed on monocyte 2)
2.Basic information (age, gender)
3.Medical history (diabetes, hypertension, hyperlipidemia, cerebrovascular disease, etc.)
4.Family history (obesity, diabetes, hypertension, hyperlipidemia, cerebrovascular disease, dementia)
5.Lifestyle history (diet, exercise habits, sleep duration, smoking history, alcohol consumption)
6.Body composition (weight, BMI, abdominal circumference), blood pressure
7.Glucose metabolism (fasting plasma glucose [FPG], HbA1c, insulin [IRI])
8.Lipid indices (total cholesterol [TC], triglycerides [TG], HDL-C, LDL-C)
9.Liver function index (GOT, GPT, rGTP)
10.Inflammation index (oxidized LDL, high-sensitivity CRP)
11.Renal function index (eGFR, CKDstage, BUN, Cre, UA, U-Alb, urine qualitative analysis, cystatin C)
12.Exploratory items
Visceral/subcutaneous fat mass
Adipocytokines (adiponectin, leptin)
Management information
Registered date
| 2022 | Year | 06 | Month | 11 | Day |
Last modified on
| 2022 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054736
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