Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-02 @ 12:27 PM
Study NCT ID:
NCT03059069
Status:
RECRUITING
Last Update Posted:
2025-02-24
First Post:
2017-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-20', 'studyFirstSubmitDate': '2017-02-15', 'studyFirstSubmitQcDate': '2017-02-16', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in Hamilton Depression Rating Scale (HDRS)', 'timeFrame': '6 months after the treatment', 'description': 'The HDRS will be scored by face-to-face interview.'}], 'secondaryOutcomes': [{'measure': 'changes in Mini-mental state examination (MMSE) score', 'timeFrame': '6 months after the treatment', 'description': 'MMSE questionnaire will be checked by careful interview and self-reported.'}, {'measure': 'glucometabolic parameters', 'timeFrame': '6 months after the treatment', 'description': 'fasting glucose (mg/dL)'}, {'measure': 'glucometabolic parameters', 'timeFrame': '6 months after the treatment', 'description': 'postprandial 2h glucose (mg/dL)'}, {'measure': 'glucometabolic parameters', 'timeFrame': '6 months after the treatment', 'description': 'fasting insulin (uIU/mL)'}, {'measure': 'glucometabolic parameters', 'timeFrame': '6 months after the treatment', 'description': 'homeostasis model assessment for insulin resistance (mg/dL•uIU/mL)'}, {'measure': 'glucometabolic parameters', 'timeFrame': '6 months after the treatment', 'description': 'aspartate aminotransferase (IU/L)'}, {'measure': 'glucometabolic parameters', 'timeFrame': '6 months after the treatment', 'description': 'alanine aminotransferase (IU/L)'}, {'measure': 'glucometabolic parameters', 'timeFrame': '6 months after the treatment', 'description': 'glycated hemoglobin (%)'}, {'measure': 'glucometabolic parameters', 'timeFrame': '6 months after the treatment', 'description': 'glycoalbumin (%)'}, {'measure': 'glucometabolic parameters', 'timeFrame': '6 months after the treatment', 'description': 'triglyceride (mg/dL)'}, {'measure': 'glucometabolic parameters', 'timeFrame': '6 months after the treatment', 'description': 'low-density lipoprotein (mg/dL)'}, {'measure': 'glucometabolic parameters', 'timeFrame': '6 months after the treatment', 'description': 'high-density lipoprotein (mg/dL)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type2 Diabetes With Depressive Mood']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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.\n\nThe 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.\n\nAs 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetic patients\n* Age ≥ 50\n* Glycemic control: HbA1c ≤ 10.0%\n* 10 ≤ Beck Depression Inventory (BDI) \\<30 points\n* Participants who can undergo contraception in case of being in childbearing period\n* Understands the study procedure, alternatives, and risks and voluntarily agrees to participate by giving written informed concent\n\nExclusion Criteria:\n\n* Type 1 diabetes, Secondary diabetes, gestational diabetes\n* Ongoing dementia treatment or anti-depressive disorder medication\n* Uncontrolled psychiatric disorder\n* BDI ≥ 30 points\n* Heavy alcoholics\n* Underlying chronic liver disease (hemochromatosis, liver cell carcinoma, autoimmune liver disease, liver cirrhosis, chronic viral hepatitis)\n* Allergy or hypersensitivity to target medication or any of its components\n* Renal failure, moderate or severe renal impairment (estimated glomerular filtration rate \\< 30 mL/min/1.73 m2), or ongoing dialysis\n* Abnormal liver function (AST/ALT \\> x3 upper normal limit)\n* History of alcohol or drug abuse in the previous 3 months\n* Premenopausal women who are nursing or pregnant\n* Human immunodeficiency virus (HIV) or human immunodeficiency virus (AIDS)\n* chronic pancreatitis or pancreatic cancer'}, 'identificationModule': {'nctId': 'NCT03059069', 'briefTitle': 'The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients', 'orgStudyIdInfo': {'id': '4-2016-0349'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glitamin', 'description': '800mg/day', 'interventionNames': ['Drug: Chonline Alphoscerate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'same shape, color, size tablet as Glitamin', 'interventionNames': ['Drug: Placebo Oral Tablet']}], 'interventions': [{'name': 'Chonline Alphoscerate', 'type': 'DRUG', 'otherNames': ['Gliatamin'], 'description': 'Patients treated with Chonline Alphoscerate as add on therapy to their medication', 'armGroupLabels': ['Glitamin']}, {'name': 'Placebo Oral Tablet', 'type': 'DRUG', 'description': 'Patients maintain their medication with either Gliatamin or placebo for 6 months.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Bong Soo Cha, MD', 'role': 'CONTACT', 'email': 'bscha@yuhs.ac', 'phone': '+82-2-2228-1932'}], 'facility': 'Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Bong-Soo Cha, MD, Ph.D', 'role': 'CONTACT', 'email': 'bscha@yuhs.ac', 'phone': '82-2-2228-5457'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}