Clinical trial NCT05360147: Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus
Official title: Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus
Cognitive function
Liraglutide
Functional near-infrared spectroscopy
Metabolic changes
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2022-05-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Changes in cognitive function from baseline to 12 weeks
timeFrame: 0 week, 12 week
Secondary outcomes:
measure: Changes of metabolic parameters from baseline to 12 weeks
timeFrame: 0 week, 12 week
measure: Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
timeFrame: 0 week, 12 week
measure: Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
timeFrame: 0 week, 12 week
measure: Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
timeFrame: 0 week, 12 week
measure: Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
timeFrame: 0 week, 12 week
measure: Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
timeFrame: 0 week, 12 week
measure: Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
timeFrame: 0 week, 12 week
measure: Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
timeFrame: 0 week, 12 week
measure: Changes of metabolic parameters from baseline to 12 weeks
timeFrame: 0 week, 12 week
measure: Changes of metabolic parameters from baseline to 12 weeks
timeFrame: 0 week, 12 week
measure: Changes of metabolic parameters from baseline to 12 weeks
timeFrame: 0 week, 12 week
measure: Changes of metabolic parameters from baseline to 12 weeks
timeFrame: 0 week, 12 week
measure: Changes of metabolic parameters from baseline to 12 weeks
timeFrame: 0 week, 12 week
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The third hospital affiliated to the Third Military Medical University
state: Chongqing
Study officials:
References: