The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Chonline Alphoscerate, Placebo Oral Tablet.
- Who it may be relevant to
- Registry conditions: Type2 Diabetes With Depressive Mood. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Chonline Alphoscerate
Patients treated with Chonline Alphoscerate as add on therapy to their medication - Drug Placebo Oral Tablet
Patients maintain their medication with either Gliatamin or placebo for 6 months.
Primary outcome measures
- changes in Hamilton Depression Rating Scale (HDRS) [Time frame: 6 months after the treatment]
Secondary outcome measures (12)
- changes in Mini-mental state examination (MMSE) score [Time frame: 6 months after the treatment]
- glucometabolic parameters [Time frame: 6 months after the treatment]
- glucometabolic parameters [Time frame: 6 months after the treatment]
- glucometabolic parameters [Time frame: 6 months after the treatment]
- glucometabolic parameters [Time frame: 6 months after the treatment]
- glucometabolic parameters [Time frame: 6 months after the treatment]
- glucometabolic parameters [Time frame: 6 months after the treatment]
- glucometabolic parameters [Time frame: 6 months after the treatment]
- glucometabolic parameters [Time frame: 6 months after the treatment]
- glucometabolic parameters [Time frame: 6 months after the treatment]
- glucometabolic parameters [Time frame: 6 months after the treatment]
- glucometabolic parameters [Time frame: 6 months after the treatment]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocr — Seoul
Identifiers
NCT: NCT03059069 · 4-2016-0349