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Trial record 6 of 165 for:    "Choline"

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

This study is currently recruiting participants.
Verified August 2017 by Soo Lim, Seoul National University Bundang Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03249259
First Posted: August 15, 2017
Last Update Posted: August 15, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Soo Lim, Seoul National University Bundang Hospital
  Purpose
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 Intervention Phase
Diabetes Mellitus, Type 2 Drug: Choline alfoscerate Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Soo Lim, Seoul National University Bundang Hospital:

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


Estimated Enrollment: 40
Actual Study Start Date: March 10, 2016
Estimated Study Completion Date: September 16, 2018
Estimated Primary Completion Date: September 16, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Choline alfoscerate
choline alfoscerate 400mg (2 caps - 1 cap bid)
Drug: Choline alfoscerate
Treatment duration is 6 months.
Other Name: Choline
Placebo Comparator: Control
Placebo (2 caps - 1 cap bid)
Drug: Placebo
Treatment duration is 6 months.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


Contacts
Contact: In Na Choi, RN 82-31-787-4999 1004ntg@naver.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi, Korea, Republic of, 463-707
Contact: Soo Lim, MD, PHD    82-31-787-7035    limsoo@snu.ac.kr   
Contact: Tae Jung Oh, MD, PHD    82-31-787-7078    ohtjmd@gmail.com   
Principal Investigator: Soo Lim, MD, PHD         
Sponsors and Collaborators
Seoul National University Bundang Hospital
  More Information

Responsible Party: Soo Lim, Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03249259     History of Changes
Other Study ID Numbers: B-1508-312-006
First Submitted: August 9, 2017
First Posted: August 15, 2017
Last Update Posted: August 15, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Choline
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Lipotropic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Lipid Regulating Agents
Nootropic Agents


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