The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients

March 14, 2019 updated by: Yonsei University
The aim of this study is to investigate the effect of Gliatamin (chonline alphoscerate) on depressive mood in type 2 diabetes patients and demonstrate the impact of improved depressive mood could be influence the patient's quality of life and glycemic control.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The prevalence of depressive disorder is higher in individuals with chronic diseases, and the screening and management of depression is emphasized. Diabetes mellitus (DM) is a class of chronic disease and the incidence of DM has been increasing. According to previous study, 31.1% of patients with DM accompanied with depressive disorders which was higher than that of subjects without DM. Furthermore, DM as well as depression is known for risk factor for dementia.

The choline metabolism involves in neuropathology of depressive disorders and individuals with depressive disorders showed the lower level of choline concentration. Choline alphoscerate is cholinergic precursor and showed the favorable clinical results in dementia management.

As pseudodementia can be presented as depressive disorder and choline alphoscerate would be an option for these cases. Therefore, the aim of this study is to investigate the effect of Gliatamin (chonline alphoscerate) on depressive mood in type 2 diabetes patients and demonstrate the impact of improved depressive mood could be influence the patient's quality of life and glycemic control.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bong-Soo Cha, MD, Ph.D
  • Phone Number: 82-2-2228-5457
  • Email: bscha@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Yonsei University College of Medicine, Department of internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 2 diabetic patients
  • Age ≥ 50
  • Glycemic control: HbA1c ≤ 10.0%
  • 10 ≤ Beck Depression Inventory (BDI) <30 points
  • Participants who can undergo contraception in case of being in childbearing period
  • Understands the study procedure, alternatives, and risks and voluntarily agrees to participate by giving written informed concent

Exclusion Criteria:

  • Type 1 diabetes, Secondary diabetes, gestational diabetes
  • Ongoing dementia treatment or anti-depressive disorder medication
  • Uncontrolled psychiatric disorder
  • BDI ≥ 30 points
  • Heavy alcoholics
  • Underlying chronic liver disease (hemochromatosis, liver cell carcinoma, autoimmune liver disease, liver cirrhosis, chronic viral hepatitis)
  • Allergy or hypersensitivity to target medication or any of its components
  • Renal failure, moderate or severe renal impairment (estimated glomerular filtration rate < 30 mL/min/1.73 m2), or ongoing dialysis
  • Abnormal liver function (AST/ALT > x3 upper normal limit)
  • History of alcohol or drug abuse in the previous 3 months
  • Premenopausal women who are nursing or pregnant
  • Human immunodeficiency virus (HIV) or human immunodeficiency virus (AIDS)
  • chronic pancreatitis or pancreatic cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glitamin
800mg/day
Drug: Chonline Alphoscerate
Patients treated with Chonline Alphoscerate as add on therapy to their medication
Other Names:
  • Gliatamin
Placebo Comparator: Placebo
same shape, color, size tablet as Glitamin
Drug: Placebo Oral Tablet
Patients maintain their medication with either Gliatamin or placebo for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in Hamilton Depression Rating Scale (HDRS)
Time Frame: 6 months after the treatment
The HDRS will be scored by face-to-face interview.
6 months after the treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in Mini-mental state examination (MMSE) score
Time Frame: 6 months after the treatment
MMSE questionnaire will be checked by careful interview and self-reported.
6 months after the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Anticipated)

June 30, 2019

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

February 15, 2017

First Submitted That Met QC Criteria

February 16, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 18, 2019

Last Update Submitted That Met QC Criteria

March 14, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2016-0349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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