Clinical trial NCT03707171: Effects of Liraglutide on the Cognitive Function in Patients With Type 2 Diabetes Mellitus
Official title: Effects of Liraglutide on the Cognitive Function in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Cognitive function
Liraglutide
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Type 2 diabetes mellitus (T2DM) can impaire cognitive function,the prevalence of Alzheimer's Disease(AD) in T2DM patients is 1.5 to 2.5 times higher than the general population.Cognitive impairment seriously affects the health and quality of life of the elderly. Prevention and treatment measures for cognitive decline in persons with T2DM has not been well studied.

Glucagon-like peptide-1 (GLP-1) is a member of an endogenous class of incretin hormones synthesized in intestinal epithelial L-cells.GLP-1 enhances glucose-dependent secretion of insulin,inhibits glucagon secretion, slows gastric emptying and reduces food intake. Liraglutide is a glucagon-like peptide type 1 (GLP-1) analogue. It has been proved that Liraglutide can improve insulin resistance and cognitive function in AD animals. Therefore, it is speculated that Liraglutide may interfere with the occurrence and development of cognitive dysfunction in patients with T2DM. In order to confirm the effects, the investigators conduct an open, prospective, positive controlled study in patients with T2DM. The effect on BMI,waist circumference, hip circumference, waist-to-hip ratio,fasting plasma glucose，glycosylated hemoglobin,blood lipids and cognitive function were measured to explore the effects of liraglutide in patients with T2DM.

The overall goal of this study is to explore the effects of liraglutide on the cognitive function in patients with type 2 diabetes mellitus and make further contribution to the improvement of cognitive function.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes。

Exclusion Criteria:

* Type 2 diabetes with acute diabetic complications.
* Type 1 diabetes.
* Other diseases affecting cognitive function (congenital dementia,brain trauma,severe heart dysfunction,severe kidney dysfunction,severe lung dysfunction,epilepsy,severe hypoglycemic coma,cerebrovascular disease,ischemic heart disease,etc).
* Alcohol abuse,mental illness and psychoactive substance abuse.
* History of thyroid disease.
* Any surgical or medical conditions that significantly influence absorption, distribution, metabolism or excretion of the intervention drugs.

Primary outcomes:
measure: Changes of cognitive function assessed by cognitive function scale after 12 weeks.
timeFrame: Baseline,4weeks,8weeks，12weeks(End of Trial)
Secondary outcomes:
measure: Changes of systolic blood pressure and diastolic blood pressure
timeFrame: Baseline,4weeks,8weeks，12weeks(End of Trial)
measure: Change of fasting plasma glucose
timeFrame: Baseline,4weeks,8weeks，12weeks(End of Trial)
measure: Change of HbA1c
timeFrame: Baseline,4weeks,8weeks，12weeks(End of Trial)
measure: Change of lipid profile
timeFrame: Baseline,4weeks,8weeks，12weeks(End of Trial)
measure: Change of liver enzymes
timeFrame: Baseline,4weeks,8weeks，12weeks(End of Trial)
measure: Change of kidney function
timeFrame: Baseline,4weeks,8weeks，12weeks(End of Trial)
measure: Change of CRP
timeFrame: Baseline,4weeks,8weeks，12weeks(End of Trial)
measure: Change of Body mass index(BMI)
timeFrame: Baseline,4weeks,8weeks，12weeks(End of Trial)
measure: Change of waist circumference
timeFrame: Baseline,4weeks,8weeks，12weeks(End of Trial)
measure: Change of hip circumference
timeFrame: Baseline,4weeks,8weeks，12weeks(End of Trial)
measure: Change of waist-to-hip ratio
timeFrame: Baseline,4weeks,8weeks，12weeks(End of Trial)
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The third hospital affiliated to the Third Military Medical University
state: Chongqing
Study officials:
References:
citation: Li Q, Jia M, Yan Z, Li Q, Sun F, He C, Li Y, Zhou X, Zhang H, Liu X, Bu X, Gao P, He H, Zhao Z, Zhu Z. Activation of Glucagon-Like Peptide-1 Receptor Ameliorates Cognitive Decline in Type 2 Diabetes Mellitus Through a Metabolism-Independent Pathway. J Am Heart Assoc. 2021 Jul 20;10(14):e020734. doi: 10.1161/JAHA.120.020734. Epub 2021 Jul 10.