Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus
Overview
- Phase
- Phase 3
- Intervention
- Liraglutide
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Third Military Medical University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Changes in cognitive function from baseline to 12 weeks
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Zhiming Zhu
Director, Center for Hypertension and Metabolic Diseases, Department of Hypertension and Endocrinology, Daping Hospital
Third Military Medical University
Eligibility Criteria
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.
Arms & Interventions
Liraglutide
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
Intervention: Liraglutide
Outcomes
Primary Outcomes
Changes in cognitive function from baseline to 12 weeks
Time Frame: 0 week, 12 week
MMSE
Secondary Outcomes
- Changes of metabolic parameters from baseline to 12 weeks(0 week, 12 week)
- Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks(0 week, 12 week)