The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
Recruiting · NCT03059069 · Interventional (participants receive a specific treatment) · Lead sponsor: Yonsei University
View the official record on ClinicalTrials.gov →Interventions studied
Chonline AlphosceratePlacebo Oral Tablet
What this trial is 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.
Who can take part
Age range
50 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center - Seoul, South Korea