Diabetes Mellitus, Type 2
Conditions
Brief summary
In this study, the investigators are going to investigate the efficacy of choline alfoscerate on improvement of cognitive function assessed by MMSE compared to plaebo.
Detailed description
The investigators will enroll patients with type 2 diabetes whose age is equal to higher than 60, and randomly assigned study drug or placebo at 1:1 ratio. The treatment duration is 6 months and extension study will be continued to 12 months.
Interventions
Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
DRUGPlacebo
Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
Sponsors
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double blind placebo controlled study.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* type 2 diabetes * baseline MMSE score 25-28
Exclusion criteria
* type 1 diabetes * diabetes ketoacidosis or hyperosmolar hyperglycemic crisis * HbA1c over than 9.0% * MMSE less than 25 * abnormal TSH levels * vitamin B12 deficiency * severe infection, perioperative state, trauma * hypopituitarism or adrenal insufficiency * any conditions that lead to hospitalization * chronic alcoholics within 1 year * any drugs that can influence to cognitive function within 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cognitive function | 6 months | Change of MMSE Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose metabolism | 6 months | Changes in HbA1c |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemia | 6 months | Incidence of hypoglycemia |
Countries
South Korea
Outcome results
None listed