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

Yonsei University

Status and phase: Enrolling; Phase 4

Conditions: Type2 Diabetes With Depressive Mood

Treatments: Drug: Placebo Oral Tablet; Drug: Chonline Alphoscerate

Study type: Interventional

Funder types: Other

Identifiers

NCT03059069

4-2016-0349

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Glitamin

Experimental group

Description:

800mg/day

Treatment:

Drug: Chonline Alphoscerate

Placebo

Placebo Comparator group

Description:

same shape, color, size tablet as Glitamin

Treatment:

Drug: Placebo Oral Tablet