Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus

NCT ID: NCT05360147

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2021-05-10

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Placebo

treated with oral antidiabetic drugs alone or combined with insulin, except for glucagon-like peptide type 1 (GLP-1) analogue

Group Type: PLACEBO_COMPARATOR

Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides

Intervention Type: DRUG

oral antidiabetic drugs (OADs) or insulin, except for glucagon-like peptide type 1 (GLP-1) analogues

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

Group Type: ACTIVE_COMPARATOR

Liraglutide

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides

oral antidiabetic drugs (OADs) or insulin, except for glucagon-like peptide type 1 (GLP-1) analogues

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhiming Zhu

Director, Center for Hypertension and Metabolic Diseases, Department of Hypertension and Endocrinology, Daping Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The third hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

LICD study

Identifier Type: -

Identifier Source: org_study_id