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

RECRUITINGPhase 4Sponsored by Yonsei University
Actively Recruiting
PhasePhase 4
SponsorYonsei University
Started2016-06-01
Est. completion2025-06-30
Eligibility
Age50 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT03059069

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.

Eligibility

Age: 50 Years+Healthy volunteers accepted
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

Conditions2

DiabetesType2 Diabetes With Depressive Mood

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