Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Liraglutide

• Registration Number: NCT05360147
• Lead Sponsor: Third Military Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-20
• Primary Completion: 2021-04-20
• Study First Submitted: 2021-04-26
• Study Completion: 2021-05-10
• Status Verified: 2022-04
• Study First Submitted QC: 2022-04-30
• Last Update Submitted: 2022-04-30
• Study First Posted: 2022-05-04
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liraglutide	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

Primary Outcome Measures

Name	Time	Method
Changes in cognitive function from baseline to 12 weeks	0 week, 12 week	MMSE

Secondary Outcome Measures

Name	Time	Method
Changes of metabolic parameters from baseline to 12 weeks	0 week, 12 week	waist circumference
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks	0 week, 12 week	TNF-a

Trial Locations

Locations (1)

The third hospital affiliated to the Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China