Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus

Sponsor
Third Military Medical University
Study ID
NCT05360147
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 20, 2021
Status verified
Apr 2022
Primary completion
Apr 20, 2021
Completion
May 10, 2021

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    treated with oral antidiabetic drugs alone or combined with insulin, except for glucagon-like peptide type 1 (GLP-1) analogue
  • Active Comparator: 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 Measure

Changes in cognitive function from baseline to 12 weeks [ Time Frame: 0 week, 12 week ]

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