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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.
The prevalence of depressive disorder is higher in individuals with chronic diseases, and the screening and management of depression is emphasized. Diabetes mellitus (DM) is a class of chronic disease and the incidence of DM has been increasing. According to previous study, 31.1% of patients with DM accompanied with depressive disorders which was higher than that of subjects without DM. Furthermore, DM as well as depression is known for risk factor for dementia.
The choline metabolism involves in neuropathology of depressive disorders and individuals with depressive disorders showed the lower level of choline concentration. Choline alphoscerate is cholinergic precursor and showed the favorable clinical results in dementia management.
As pseudodementia can be presented as depressive disorder and choline alphoscerate would be an option for these cases. Therefore, 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glitamin | Experimental | 800mg/day |
|
| Placebo | Placebo Comparator | same shape, color, size tablet as Glitamin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chonline Alphoscerate | Drug | Patients treated with Chonline Alphoscerate as add on therapy to their medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| changes in Hamilton Depression Rating Scale (HDRS) | The HDRS will be scored by face-to-face interview. | 6 months after the treatment |
| Measure | Description | Time Frame |
|---|---|---|
| changes in Mini-mental state examination (MMSE) score | MMSE questionnaire will be checked by careful interview and self-reported. | 6 months after the treatment |
| glucometabolic parameters | fasting glucose (mg/dL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bong-Soo Cha, MD, Ph.D | Contact | 82-2-2228-5457 | bscha@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center | Recruiting | Seoul | 03722 | South Korea |
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| Placebo Oral Tablet | Drug | Patients maintain their medication with either Gliatamin or placebo for 6 months. |
|
| 6 months after the treatment |
| glucometabolic parameters | postprandial 2h glucose (mg/dL) | 6 months after the treatment |
| glucometabolic parameters | fasting insulin (uIU/mL) | 6 months after the treatment |
| glucometabolic parameters | homeostasis model assessment for insulin resistance (mg/dL•uIU/mL) | 6 months after the treatment |
| glucometabolic parameters | aspartate aminotransferase (IU/L) | 6 months after the treatment |
| glucometabolic parameters | alanine aminotransferase (IU/L) | 6 months after the treatment |
| glucometabolic parameters | glycated hemoglobin (%) | 6 months after the treatment |
| glucometabolic parameters | glycoalbumin (%) | 6 months after the treatment |
| glucometabolic parameters | triglyceride (mg/dL) | 6 months after the treatment |
| glucometabolic parameters | low-density lipoprotein (mg/dL) | 6 months after the treatment |
| glucometabolic parameters | high-density lipoprotein (mg/dL) | 6 months after the treatment |
|