UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017929
Receipt No. 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

* 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 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
Email 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
Email nsato@kyotolan.hosp.go.jp

Sponsor
Institute National Hospital Organization Kyoto Medical Center
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018942

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.