Effect of Gliatamin on depression in type 2 diabetes patients
The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
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 |
| Enrollment | 60 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT03059069 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are type 2 diabetic patients aged 50 and older with moderate depressive symptoms.
Not a fit: Patients with type 1 diabetes, severe depression, or those currently on antidepressant medications may not benefit from this study.
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 performed: Previous studies have indicated potential benefits of choline supplementation in managing depressive symptoms, suggesting a promising avenue for this approach.
Eligibility criteria
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 this trial is running
Seoul
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.