UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017929 |
|---|---|
| Receipt number | R000018942 |
| Scientific Title | The elucidation of a predictor for the onset of decline of cognitive function and dementia using large-scale cohort of diabetic and obese patients |
| Date of disclosure of the study information | 2015/06/17 |
| Last modified on | 2015/06/19 12:17:14 |
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Basic information
Public title
The elucidation of a predictor for the onset of decline of cognitive function and dementia using large-scale cohort of diabetic and obese patients
Acronym
JOMS/J-DOS2
Scientific Title
The elucidation of a predictor for the onset of decline of cognitive function and dementia using large-scale cohort of diabetic and obese patients
Scientific Title:Acronym
JOMS/J-DOS2
Region
| Japan |
Condition
Condition
1. Type 2 Diabetes
2. Obesity
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This aim of this study is to examine the association of the decline of cognitive functional and dementia in Japanese patients with diabetes and obesity and to elucidate effective indicators.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
MMSE (Mini-Mental State Examination)
Key secondary outcomes
FAB (Frontal Assessment Battery), 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) Type 2 diabetes and/or Obesity.
2) Lower age limit: 20 years old
3) Gender: male and female.
4) Outpatients and/or inpatients seeking treatment for lifestyle disease diseases in the hospitals of National Hospital Organization.
5) Patients who have provided written informed consent.
Key exclusion criteria
1) Secondary obesity associated with endocrine disorders.
2) Severe liver dysfunction and liver cirrhosis.
3) Severe renal dysfunction (serum creatinine >= 3.0mg/dl).
4) Patients who are pregnant or under preconceptional care.
5) Subjects judged by the investigator/project leader to be ineligible for other reasons.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriko Asahara |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Diabetic Research, Clinical Research Institute
Zip code
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL
075-641-9161
nsato@kyotolan.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Noriko Asahara |
Organization
National Hospital Organization Kyoto Medical Center
Division name
Division of Diabetic Research, Clinical Research Institute
Zip code
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto
TEL
075-641-9161
Homepage URL
nsato@kyotolan.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
H26-NHO(Diabetes)-02
Org. issuing International ID_1
National Hospital Organization
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都医療センター（京都府）、小倉医療センター（福岡県）、名古屋医療センター（愛知県）、三重病院（三重県）、長崎川棚医療センター（長崎県）、九州医療センター（福岡県）、徳島病院（徳島県）、金沢医療センター（石川県）、熊本医療センター（熊本県）、函館病院（北海道）、三重中央医療センター（三重県）、埼玉病院（埼玉県）、広島西医療センター（広島県）、西別府病院（大分県）、西群馬病院（群馬県）、千葉東病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 17 | 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
| 2015 | Year | 01 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Main Observation Item:
1. Plasma glucose level, HbA1c, serum insulin level
2. Adipocytokine (Adiponectin, Leptin)
3. Body weight, BMI, waist circumference
Management information
Registered date
| 2015 | Year | 06 | Month | 16 | Day |
Last modified on
| 2015 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018942
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
