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Patients with diabetes are susceptible to dementia, but regular therapy fails to reduce the risk of dementia. In previous observational study, the investigators found that liraglutide can improve cognitive function in patients with T2DM through a metabolism-independent pathway. Here the investigators aim to further verify such effects through a randomized, controlled study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | treated with oral antidiabetic drugs alone or combined with insulin, except for glucagon-like peptide type 1 (GLP-1) analogue |
|
| Liraglutide | Active Comparator | liraglutide started at an initial dose of 0.6 mg/day and a maximum dose of 1.8mg/day, adjusted once a week when hyperglycemia was uncontrolled |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liraglutide | Drug | Liraglutide is a glucagon-like peptide type 1 (GLP-1) analogue. We had fond its cognitive improvement effects in an observational study. In order to confirm the effects, the investigators conduct a randomized, controlled study. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in cognitive function from baseline to 12 weeks | MMSE | 0 week, 12 week |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of metabolic parameters from baseline to 12 weeks | Systolic and diastolic blood pressure | 0 week, 12 week |
| Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The third hospital affiliated to the Third Military Medical University | Chongqing | Chongqing Municipality | 400042 | China |
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| Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides | Drug | oral antidiabetic drugs (OADs) or insulin, except for glucagon-like peptide type 1 (GLP-1) analogues |
|
Aβ42
| 0 week, 12 week |
| Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks | tau | 0 week, 12 week |
| Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks | P-tau | 0 week, 12 week |
| Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks | TDP-43 | 0 week, 12 week |
| Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks | IL-6 | 0 week, 12 week |
| Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks | IL-8 | 0 week, 12 week |
| Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks | TNF-a | 0 week, 12 week |
| Changes of metabolic parameters from baseline to 12 weeks | HbA1c | 0 week, 12 week |
| Changes of metabolic parameters from baseline to 12 weeks | fasting plasma glucose | 0 week, 12 week |
| Changes of metabolic parameters from baseline to 12 weeks | body mass index | 0 week, 12 week |
| Changes of metabolic parameters from baseline to 12 weeks | lipid profile | 0 week, 12 week |
| Changes of metabolic parameters from baseline to 12 weeks | waist circumference | 0 week, 12 week |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069450 | Liraglutide |
| D013453 | Sulfonylurea Compounds |
| D045162 | Thiazolidinediones |
| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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