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Completed

NCT Number: NCT03249259

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Choline alfoscerate

Drug

Treatment duration is 6 months and can be extended to 12 months with participant's agreement.

Other names: Choline

Placebo

Drug

Treatment duration is 6 months and can be extended to 12 months with participant's agreement.

Primary outcomes

  1. Cognitive function

    Time frame: 6 months

    Change of MMSE Score

Secondary outcomes

  1. Glucose metabolism

    Time frame: 6 months

    Changes in HbA1c

  2. Glucose metabolism

    Time frame: 6 months

    Changes in fasting glucose concentration

Other outcomes

  1. Hypoglycemia

    Time frame: 6 months

    Incidence of hypoglycemia

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 15, 2017
Registry last updated
Oct 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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