NCT03249259
Completed
Phase 3
The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes
ConditionsDiabetes Mellitus, Type 2
Overview
- Phase
- Phase 3
- Intervention
- Choline alfoscerate
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Seoul National University Bundang Hospital
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Cognitive function
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Soo Lim
Professor
Seoul National University Bundang Hospital
Eligibility Criteria
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
Arms & Interventions
Choline alfoscerate
choline alfoscerate 400mg (2 caps - 1 cap bid)
Intervention: Choline alfoscerate
Control
Placebo (2 caps - 1 cap bid)
Intervention: Placebo
Outcomes
Primary Outcomes
Cognitive function
Time Frame: 6 months
Change of MMSE Score
Secondary Outcomes
- Glucose metabolism(6 months)
Study Sites (1)
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