THe elucidation of risk factors for Cognitive Decline/ Frailty in Diabetes and Obesity-To establish effective early detection and prognosis prediction methods
Not Applicable
Recruiting
- Conditions
- type2 diabetes mellitus, obesity
- Registration Number
- JPRN-UMIN000051269
- Lead Sponsor
- Clinical Research Institute,National Hospital Organization, Kyoto Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method 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