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The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03249259
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Choline alfoscerate Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: double blind placebo controlled study.
Primary Purpose: Treatment
Official Title: The Effect of Choline Alfoscerate on Improvement of Cognitive Function in Elderly Patients With Diabetes
Actual Study Start Date : March 10, 2016
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Choline alfoscerate
choline alfoscerate 400mg (2 caps - 1 cap bid)
Drug: Choline alfoscerate
Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
Other Name: Choline

Placebo Comparator: Control
Placebo (2 caps - 1 cap bid)
Drug: Placebo
Treatment duration is 6 months and can be extended to 12 months with participant's agreement.




Primary Outcome Measures :
  1. Cognitive function [ Time Frame: 6 months ]
    Change of MMSE Score


Secondary Outcome Measures :
  1. Glucose metabolism [ Time Frame: 6 months ]
    Changes in HbA1c

  2. Glucose metabolism [ Time Frame: 6 months ]
    Changes in fasting glucose concentration


Other Outcome Measures:
  1. Hypoglycemia [ Time Frame: 6 months ]
    Incidence of hypoglycemia



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249259


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
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Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03249259    
Other Study ID Numbers: B-1508-312-006
First Posted: August 15, 2017    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Choline
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents