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RecruitingPhase 4NCT03059069

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

Sponsor

Yonsei University

Enrollment

60 participants

Start Date

Jun 1, 2016

Study Type

INTERVENTIONAL

Conditions

Type2 Diabetes With Depressive Mood

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

Min Age: 50 Years

Inclusion Criteria6

  • Type 2 diabetic patients
  • Age ≥ 50
  • Glycemic control: HbA1c ≤ 10.0%
  • ≤ 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 Criteria13

  • 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

Interventions

DRUGChonline Alphoscerate

Patients treated with Chonline Alphoscerate as add on therapy to their medication

DRUGPlacebo Oral Tablet

Patients maintain their medication with either Gliatamin or placebo for 6 months.

Locations(1)

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

Seoul, South Korea

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NCT03059069