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Clinical Trial Details

Trial ID: L3665
Source ID: NCT03059069
Associated Drug: Chonline Alphoscerate
Title: The Effect of Gliatamin (Chonline Alphoscerate) on Depressive Mood in Type 2 Diabetes Patients
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type2 Diabetes With Depressive Mood
Interventions: DRUG: Chonline Alphoscerate|DRUG: Placebo Oral Tablet
Outcome Measures: Primary: changes in Hamilton Depression Rating Scale (HDRS), The HDRS will be scored by face-to-face interview., 6 months after the treatment | Secondary: 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), 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
Sponsor/Collaborators: Sponsor: Yonsei University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2016-06-01
Completion Date: 2025-06-30
Results First Posted:
Last Update Posted: 2025-02-24
Locations: Yonsei University College of Medicine, Department of Internal Medicine, Division of Endocrinology, Severance Hospital, Diabetes Center, Seoul, 03722, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT03059069