Japan-Multidomain Intervention Trial for Prevention of Dementia in Older Adults with Diabetes.
- Conditions
- Type 2 diabetes mellitus with mild cognitive impairment
- Registration Number
- JPRN-UMIN000035911
- Lead Sponsor
- ational Center for Geriatrics and Gerontology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 300
Not provided
1) Metabolic control is extremely poor (fasting plasma glucose level over 250 mg/dl; or urinay ketone bodies moderately positive above. 2) New hemorrahaging in the ocular fundus caused by proliferative retinopathy. 3) Renal failure. 4) Ischemic heart disease and cardiopulmonary disorders. 5) Presence of bone or joint disease. 6) Acute infectious disease. 7) Diabetes gangrene. 8) Severe autonomic neuropathy. 9) Parkinson's disease, apoplexy, Huntington's disease, normal pressure hydrocephalus, brain tumors, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, aphasia, epilepsy, subdural hematoma, encephalitis/meningitis, multiple sclerosis, or decreased cognitive function due to head injury. 10) Any local lesion such as cerebral infarction(s) detected by CT or MRI before enrollment that can greatly affect the cognitive function 11) History of major depression, bipolar disorder, schizophrenia, or alcohol/drug abuse; current serious or unstable disease 12) Patients unsuitable for treatment due to vitamin B1/B12 and/or folate deficiency, syphilis, or thyroid dysfunction 13) Patients deemed ineligible for enrollment by the responsible researcher or co-researcher at each institution
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in composite score of cognitive function from baseline to 18-month follow-up.
- Secondary Outcome Measures
Name Time Method 1) Change in composite score of cognitive function from baseline to 6-month follow-up. 2) Change in scores of each cognitive function from baseline to 6/18-month follow-up. 3) Change in Barthel Index and Lawton Index from baseleine to 6/18-month follow-up. 4) Change in status of frailty and sarcopenia from baseline to 6/18-month follow-up. 5) Change in the number of medications. 6) Cost-effectiveness. 7) Change in each result of comprehensive geriatric assement from baseline to 6/18-month follow-up. 8) Change in laboratory and urinary markers from baseline to 6/18-month follow-up.