The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Choline alfoscerate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
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
- any drugs that can influence to cognitive function within 3 months
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Choline alfoscerate
Control
Arm Description
choline alfoscerate 400mg (2 caps - 1 cap bid)
Placebo (2 caps - 1 cap bid)
Outcomes
Primary Outcome Measures
Cognitive function
Change of MMSE Score
Secondary Outcome Measures
Glucose metabolism
Changes in HbA1c
Glucose metabolism
Changes in fasting glucose concentration
Full Information
NCT ID
NCT03249259
First Posted
August 9, 2017
Last Updated
October 4, 2019
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03249259
Brief Title
The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes
Official Title
The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 10, 2016 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
double blind placebo controlled study.
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Choline alfoscerate
Arm Type
Experimental
Arm Description
choline alfoscerate 400mg (2 caps - 1 cap bid)
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebo (2 caps - 1 cap bid)
Intervention Type
Drug
Intervention Name(s)
Choline alfoscerate
Other Intervention Name(s)
Choline
Intervention Description
Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
Primary Outcome Measure Information:
Title
Cognitive function
Description
Change of MMSE Score
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Glucose metabolism
Description
Changes in HbA1c
Time Frame
6 months
Title
Glucose metabolism
Description
Changes in fasting glucose concentration
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Hypoglycemia
Description
Incidence of hypoglycemia
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
any drugs that can influence to cognitive function within 3 months
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes
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