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Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Liraglutide
Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides
Sponsored by
Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Type 2 Diabetes Mellitus, Cognitive function, Liraglutide, Functional near-infrared spectroscopy, Metabolic changes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The third hospital affiliated to the Third Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Liraglutide

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in cognitive function from baseline to 12 weeks
MMSE

Secondary Outcome Measures

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

Full Information

First Posted
April 26, 2021
Last Updated
April 30, 2022
Sponsor
Third Military Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05360147
Brief Title
Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus
Official Title
Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
April 20, 2021 (Actual)
Study Completion Date
May 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Military Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Type 2 Diabetes Mellitus, Cognitive function, Liraglutide, Functional near-infrared spectroscopy, Metabolic changes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
treated with oral antidiabetic drugs alone or combined with insulin, except for glucagon-like peptide type 1 (GLP-1) analogue
Arm Title
Liraglutide
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Liraglutide
Intervention Description
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
Intervention Name(s)
Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides
Intervention Description
oral antidiabetic drugs (OADs) or insulin, except for glucagon-like peptide type 1 (GLP-1) analogues
Primary Outcome Measure Information:
Title
Changes in cognitive function from baseline to 12 weeks
Description
MMSE
Time Frame
0 week, 12 week
Secondary Outcome Measure Information:
Title
Changes of metabolic parameters from baseline to 12 weeks
Description
Systolic and diastolic blood pressure
Time Frame
0 week, 12 week
Title
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
Description
Aβ42
Time Frame
0 week, 12 week
Title
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
Description
tau
Time Frame
0 week, 12 week
Title
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
Description
P-tau
Time Frame
0 week, 12 week
Title
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
Description
TDP-43
Time Frame
0 week, 12 week
Title
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
Description
IL-6
Time Frame
0 week, 12 week
Title
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
Description
IL-8
Time Frame
0 week, 12 week
Title
Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks
Description
TNF-a
Time Frame
0 week, 12 week
Title
Changes of metabolic parameters from baseline to 12 weeks
Description
HbA1c
Time Frame
0 week, 12 week
Title
Changes of metabolic parameters from baseline to 12 weeks
Description
fasting plasma glucose
Time Frame
0 week, 12 week
Title
Changes of metabolic parameters from baseline to 12 weeks
Description
body mass index
Time Frame
0 week, 12 week
Title
Changes of metabolic parameters from baseline to 12 weeks
Description
lipid profile
Time Frame
0 week, 12 week
Title
Changes of metabolic parameters from baseline to 12 weeks
Description
waist circumference
Time Frame
0 week, 12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
The third hospital affiliated to the Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China

12. IPD Sharing Statement

Learn more about this trial

Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus

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