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| Name | Class |
|---|---|
| Seoul National University | OTHER |
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The aims this study is to explore the effect of a GLP-1 receptor agonist on the degree of brain activation and connectivity obtained by functional magnetic resonance imaging in lean and obese type 2 diabetes
Fifteen lean [BMI(body mass index) less than 23 kg/m2] type 2 diabetes subjects and fifteen obese (BMI more than 26 kg/m2) subjects with type 2 diabetes treated by diet and/or metformin, SU(sulfonylurea), DPP4-inhibitors(Dipeptidyl peptidase-4 inhibitor) will be recruited. Every subject will be studied on 2 separate days in random order with 1-2 week intervals. These participants will be injected either normal saline or 10 mcg of lixisenatide in a cross-over fashion. Neuroimaging composed with resting-12-min, visual stimulation task-12-min, T1-5-min, and diffusion tensor image-12-min will be proceeded. Ad lib buffet will be provided to every participant and the intake will be measured. Surveys about appetite and mood will be done before and after neuroimaging test and buffet eating.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lixisenatide injection | Experimental | intervention : Lyxumia® pen injection 10 microgram (Lixisenatide) subcutaneous injection 30 minutes before functional MRI |
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| Normal saline | Placebo Comparator | control : normal saline 0.3 cc subcutaneous injection before functional MRI |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lixisenatide | Drug | Colorless, transparent liquid contained in a glass prefilled syringe pen-like injection (GLP-1 receptor agonist) |
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| Measure | Description | Time Frame |
|---|---|---|
| Difference of BOLD (Blood oxygenation level-dependent) signal in hypothalamus | 10min (40 min after injection) | |
| Whole brain connectivity | 20min (50 min after injection) |
| Measure | Description | Time Frame |
|---|---|---|
| appetite change | Visual analoge scale-questionnaire consisting of 8 questions (Flint, Raben, Blundell, & Astrup, 2000) | -30min, 45min(after fMRI), 70min(after buffet) |
| mood change | Visual analoge scale-questionnaire consisting of 16 questions (Boggieo et al., 2008) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Young Min Cho, MD, PHD | Associate Professor Division of Endocrinology and Metabolism Department of Internal Medicine Seoul National University College of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C479460 | lixisenatide |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Placebo | Other | Normal saline injection before performing fMRI |
|
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| -30min, 45min(after fMRI), 70min(after buffet) |
| intake of food in the buffet | It will be provided quantified juice and milk , boiled eggs, bread , bananas and chocolate bars. Participants may eat freely for 20 minutes. Then measure the intake of participants. Compares whether the difference in food intake pattern . | 50min |