Effect of Gliatamin on depression in type 2 diabetes patients
Official title: The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
Run by Yonsei University · NCT03059069 · Data updated 2026-11-12
This study tests if Gliatamin can help improve mood and diabetes management in people with type 2 diabetes who are experiencing depression.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | June 1, 2016 |
| Main results expected | June 30, 2025 |
| Study ends | June 30, 2025 |
| Registry record updated | February 24, 2025 |
| Trial ID | NCT03059069 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are type 2 diabetic patients aged 50 and older with moderate depressive symptoms.
✕Probably not a fit
Patients with type 1 diabetes, severe depression, or those currently on antidepressant medications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the impact of Gliatamin (choline alphoscerate) on depressive mood among patients with type 2 diabetes. It aims to determine whether improving depressive symptoms can enhance the quality of life and glycemic control in these individuals. The study includes a comparison between the effects of Gliatamin and a placebo. Participants will be monitored for changes in mood and diabetes management over the course of the intervention.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the mental health and overall quality of life for patients with type 2 diabetes.
How similar studies have gone: Previous studies have indicated potential benefits of choline supplementation in managing depressive symptoms, suggesting a promising avenue for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Bong-Soo Cha, MD, Ph.D
- Email: bscha@yuhs.ac
- Phone: 82-2-2228-5457
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.