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Completed

NCT Number: NCT05360147

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The third hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Changes in cognitive function from baseline to 12 weeks

    Time frame: 0 week, 12 week

    MMSE

Secondary outcomes

  1. Changes of metabolic parameters from baseline to 12 weeks

    Time frame: 0 week, 12 week

    Systolic and diastolic blood pressure

  2. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks

    Time frame: 0 week, 12 week

    Aβ42

  3. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks

    Time frame: 0 week, 12 week

    tau

  4. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks

    Time frame: 0 week, 12 week

    P-tau

  5. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks

    Time frame: 0 week, 12 week

    TDP-43

  6. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks

    Time frame: 0 week, 12 week

    IL-6

  7. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks

    Time frame: 0 week, 12 week

    IL-8

  8. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks

    Time frame: 0 week, 12 week

    TNF-a

  9. Changes of metabolic parameters from baseline to 12 weeks

    Time frame: 0 week, 12 week

    HbA1c

  10. Changes of metabolic parameters from baseline to 12 weeks

    Time frame: 0 week, 12 week

    fasting plasma glucose

  11. Changes of metabolic parameters from baseline to 12 weeks

    Time frame: 0 week, 12 week

    body mass index

  12. Changes of metabolic parameters from baseline to 12 weeks

    Time frame: 0 week, 12 week

    lipid profile

  13. Changes of metabolic parameters from baseline to 12 weeks

    Time frame: 0 week, 12 week

    waist circumference

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 4, 2022
Registry last updated
May 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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