Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus

Study Overview
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Brief Summary
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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.

Official Title
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Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Liraglutide
* Drug: Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with Type 2 Diabetes Mellitus Exclusion Criteria: T2DM with acute diabetic complications; type 1 diabetes; other diseases affecting cognitive function (e.g., congenital dementia, brain trauma, epilepsy, severe hypoglycemic coma, cerebrovascular disease, ischemic heart disease, renal dysfunction); alcohol abuse, mental illness, and psychoactive substance abuse; history of thyroid disease; any surgical or medical conditions that could significantly influence the absorption, distribution, metabolism, or excretion of interventional drugs; unwillingness to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>treated with oral antidiabetic drugs alone or combined with insulin, except for glucagon-like peptide type 1 (GLP-1) analogue | Drug: Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides<br>* oral antidiabetic drugs (OADs) or insulin, except for glucagon-like peptide type 1 (GLP-1) analogues<br>|
| Active Comparator: Liraglutide<br>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 | Drug: Liraglutide<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cognitive function from baseline to 12 weeks | MMSE | 0 week, 12 week | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 Diabetes Mellitus, Cognitive function, Liraglutide, Functional near-infrared spectroscopy, Metabolic changes