Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05360147
• Other study ID #: LICD study
• Status: Completed
• Phase: Phase 3
• Start date: January 20, 2021
• Est. completion date: May 10, 2021

Study information

• Verified date: April 2022
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 10, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Liraglutide
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.
• Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, a-Glucosidase inhibitors, and Glinides
oral antidiabetic drugs (OADs) or insulin, except for glucagon-like peptide type 1 (GLP-1) analogues

Locations

Country	Name	City	State
China	The third hospital affiliated to the Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in cognitive function from baseline to 12 weeks	MMSE	0 week, 12 week
Secondary	Changes of metabolic parameters from baseline to 12 weeks	Systolic and diastolic blood pressure	0 week, 12 week
Secondary	Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks	Aß42	0 week, 12 week
Secondary	Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks	tau	0 week, 12 week
Secondary	Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks	P-tau	0 week, 12 week
Secondary	Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks	TDP-43	0 week, 12 week
Secondary	Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks	IL-6	0 week, 12 week
Secondary	Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks	IL-8	0 week, 12 week
Secondary	Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks	TNF-a	0 week, 12 week
Secondary	Changes of metabolic parameters from baseline to 12 weeks	HbA1c	0 week, 12 week
Secondary	Changes of metabolic parameters from baseline to 12 weeks	fasting plasma glucose	0 week, 12 week
Secondary	Changes of metabolic parameters from baseline to 12 weeks	body mass index	0 week, 12 week
Secondary	Changes of metabolic parameters from baseline to 12 weeks	lipid profile	0 week, 12 week
Secondary	Changes of metabolic parameters from baseline to 12 weeks	waist circumference	0 week, 12 week