type2 diabetes mellitus, obesity
Conditions
Interventions
None listed
Sponsors
Clinical Research Institute,National Hospital Organization, Kyoto Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactNoriko Asahara
National Hospital Organization, Kyoto Medical Center Department of Endocrinology, Metabolism and Hypertension Research, Clinical Research Institute
Outcome results
None listed