Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus

• Sponsor: Third Military Medical University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05360147
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.6
• Patients Per Site Per Month: 8.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: Liraglutide; Drug: Oral antidiabetic drugs: Metformin, Sulfonylureas (2nd generation), Thiazolidinediones, α-Glucosidase inhibitors, and Glinides	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Liraglutide Improve Cognitive Function in Patients With Type 2 Diabetes Mellitus
• Actual Study Start Date: Jan 20, 2021
• Actual Primary Completion Date: Apr 20, 2021
• Actual Study Completion Date: May 10, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Changes in cognitive function from baseline to 12 weeks [0 week, 12 week]

   MMSE

Secondary Outcome Measures

1. Changes of metabolic parameters from baseline to 12 weeks [0 week, 12 week]

   Systolic and diastolic blood pressure

2. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks [0 week, 12 week]

   Aβ42

3. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks [0 week, 12 week]

   tau

4. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks [0 week, 12 week]

   P-tau

5. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks [0 week, 12 week]

   TDP-43

6. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks [0 week, 12 week]

   IL-6

7. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks [0 week, 12 week]

   IL-8

8. Changes of Alzheimer's disease-associated serum markers from baseline to 12 weeks [0 week, 12 week]

   TNF-a

9. Changes of metabolic parameters from baseline to 12 weeks [0 week, 12 week]

   HbA1c

10. Changes of metabolic parameters from baseline to 12 weeks [0 week, 12 week]

    fasting plasma glucose

11. Changes of metabolic parameters from baseline to 12 weeks [0 week, 12 week]

    body mass index

12. Changes of metabolic parameters from baseline to 12 weeks [0 week, 12 week]

    lipid profile

13. Changes of metabolic parameters from baseline to 12 weeks [0 week, 12 week]

    waist circumference

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The third hospital affiliated to the Third Military Medical University	Chongqing	Chongqing	China	400042

Sponsors and Collaborators

• Third Military Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhiming Zhu, Director, Center for Hypertension and Metabolic Diseases, Department of Hypertension and Endocrinology, Daping Hospital, Third Military Medical University
• ClinicalTrials.gov Identifier: NCT05360147
• Other Study ID Numbers: LICD study
• First Posted: May 4, 2022
• Last Update Posted: May 4, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Zhiming Zhu, Director, Center for Hypertension and Metabolic Diseases, Department of Hypertension and Endocrinology, Daping Hospital, Third Military Medical University: Type 2 Diabetes Mellitus; Cognitive function; Liraglutide; Functional near-infrared spectroscopy; Metabolic changes
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Metformin; Liraglutide; Hypoglycemic Agents; 2,4-thiazolidinedione

Study Results

No Results Posted as of May 4, 2022