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Recruiting Phase 4

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

About this study

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.

Condition
Type2 Diabetes With Depressive Mood
Tested
Chonline Alphoscerate, Placebo Oral Tablet
Sponsor
Yonsei University

Who can join

Age
50 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 8

  • Minimum age: 50 years
  • Study condition: Type2 Diabetes With Depressive Mood
  • 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 13

  • 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

1 site, 1 recruiting

Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center

Seoul, South Korea

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.