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

Phase 4

• Conditions: Type2 Diabetes With Depressive Mood
• Interventions: Drug: Chonline Alphoscerate; Drug: Placebo Oral Tablet

• Registration Number: NCT03059069
• Lead Sponsor: Yonsei University

Brief Summary

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.

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 Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-23
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-14
• Last Update Posted: 2019-03-18
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glitamin	Chonline Alphoscerate	800mg/day
Placebo	Placebo Oral Tablet	same shape, color, size tablet as Glitamin

Primary Outcome Measures

Name	Time	Method
changes in Hamilton Depression Rating Scale (HDRS)	6 months after the treatment	The HDRS will be scored by face-to-face interview.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center; 🇰🇷 Seoul, Korea, Republic of