Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides; Drug: Liraglutide

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400042
      • The third hospital affiliated to the Third Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; treated with oral antidiabetic drugs alone or combined with insulin, except for glucagon-like peptide type 1 (GLP-1) analogue	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
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in cognitive function from baseline to 12 weeks	MMSE	0 week, 12 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of metabolic parameters from baseline to 12 weeks	Systolic and diastolic blood pressure	0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks	Aβ42	0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks	tau	0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks	P-tau	0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks	TDP-43	0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks	IL-6	0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks	IL-8	0 week, 12 week
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks	TNF-a	0 week, 12 week
Changes of metabolic parameters from baseline to 12 weeks	HbA1c	0 week, 12 week
Changes of metabolic parameters from baseline to 12 weeks	fasting plasma glucose	0 week, 12 week
Changes of metabolic parameters from baseline to 12 weeks	body mass index	0 week, 12 week
Changes of metabolic parameters from baseline to 12 weeks	lipid profile	0 week, 12 week
Changes of metabolic parameters from baseline to 12 weeks	waist circumference	0 week, 12 week

Collaborators and Investigators

• Sponsor: Third Military Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2021
• Primary Completion (ACTUAL): April 20, 2021
• Study Completion (ACTUAL): May 10, 2021

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 30, 2022
• First Posted (ACTUAL): May 4, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2022
• Last Update Submitted That Met QC Criteria: April 30, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Liraglutide; Cognitive function; Type 2 Diabetes Mellitus; Functional near-infrared spectroscopy; Metabolic changes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Liraglutide; Hypoglycemic Agents; Metformin; 2,4-thiazolidinedione
• Other Study ID Numbers: LICD study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No