Clinical trial NCT03059069: The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
Official title: The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Type2 Diabetes With Depressive Mood
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: changes in Hamilton Depression Rating Scale (HDRS)
timeFrame: 6 months after the treatment
Secondary outcomes:
measure: changes in Mini-mental state examination (MMSE) score
timeFrame: 6 months after the treatment
measure: glucometabolic parameters
timeFrame: 6 months after the treatment
measure: glucometabolic parameters
timeFrame: 6 months after the treatment
measure: glucometabolic parameters
timeFrame: 6 months after the treatment
measure: glucometabolic parameters
timeFrame: 6 months after the treatment
measure: glucometabolic parameters
timeFrame: 6 months after the treatment
measure: glucometabolic parameters
timeFrame: 6 months after the treatment
measure: glucometabolic parameters
timeFrame: 6 months after the treatment
measure: glucometabolic parameters
timeFrame: 6 months after the treatment
measure: glucometabolic parameters
timeFrame: 6 months after the treatment
measure: glucometabolic parameters
timeFrame: 6 months after the treatment
measure: glucometabolic parameters
timeFrame: 6 months after the treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center
Study officials:
References: