Type 2 diabetes mellitus with mild cognitive impairment
Conditions
Interventions
Multidomain intervention including vascular risk factor management, exercise, diet and social engagement. Diabetes, hypertension, and dyslipidemia are treated according to their guidelines in Japan. T
Sponsors
National Center for Geriatrics and Gerontology
National Center for Geriatrics and Gerontology and 16 institusions in Japan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who 1) are diagnosed with type 2 diabetes mellitus 2) aged 70-85 at the time of enrollment 3) have no or slight impairment of basic acitivities of daily living (Barthel Index >= 80) 4) have cognitive impairment (MoCA-J < 26) 5) have MMSE score of 21-30 6) are outpatients or who have stable clinical corse for more than 4 weeks after their latest hospitalization or institutionalization and who have no need to change the medical examination classification during monitoring period. 7) are accompanied by a co-participant (study partner). The study partner must be physically and mentally healthy, contact the patient about once a week, and know how the patient lives. Preferably, the study partner should be able to make many visits together with the patient during the monitoring period. 8) have provided a written informed consent by subjects or their study partners.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in composite score of cognitive function from baseline to 18-month follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactTakashi Sakurai
National Center for Geriatrics and Gerontology Center for Comprehensive Care and Research on Memory Disorders
Outcome results
None listed