Effects of Liraglutide on the Cognitive Function in Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Effects of Liraglutide on the Cognitive Function in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03707171
• Other study ID #: Liraglutide
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2018
• Est. completion date: May 1, 2019

Study information

• Verified date: July 2019
• Source: Third Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 1, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Liraglutide
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.
• placebo
Any hypoglycemic drugs except glucagon-like peptide type 1 (GLP-1) analogue.

Locations

Country	Name	City	State
China	The third hospital affiliated to the Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Third Military Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of cognitive function assessed by cognitive function scale after 12 weeks.	The cognitive function will be calculated from performance on the following measures: (1)Digit Span Test(DST);(2) Rey Auditory Verbal Learning(RAVL);(3) Long-Delay Free Recall(LDFR);(4) Trail Making Test(TMT);(5) Animal Naming Test(ANT);(6) Clock Drawing Test(CDT);(7)Minimum Mental State Examination(MMSE);(8)Memory and executive screening(MES);(8)functional near-infrared spectroscopy.	Baseline,4weeks,8weeks,12weeks(End of Trial)
Secondary	Changes of systolic blood pressure and diastolic blood pressure	Change of systolic blood pressure and diastolic blood pressure compared with baseline, and between the intervention and control group at the end of the study (12 weeks)	Baseline,4weeks,8weeks,12weeks(End of Trial)
Secondary	Change of fasting plasma glucose	Change of fasting plasma glucose compared with baseline, and between the intervention and control group at the end of the study (12 weeks)	Baseline,4weeks,8weeks,12weeks(End of Trial)
Secondary	Change of HbA1c	Change of HbA1c compared with baseline, and between the intervention and control group at the end of the study (12 weeks)	Baseline,4weeks,8weeks,12weeks(End of Trial)
Secondary	Change of lipid profile	Change of lipids profiles (TC, HDL-C, LDL-C, TG) in mmol/L compared with baseline, and between the intervention and control group at the end of the study (12 weeks)	Baseline,4weeks,8weeks,12weeks(End of Trial)
Secondary	Change of liver enzymes	Change of liver enzymes (ALT, AST in IU/L) compared with baseline, and between the intervention and control group at the end of the study (12 weeks)	Baseline,4weeks,8weeks,12weeks(End of Trial)
Secondary	Change of kidney function	Change of kidney function(serum creatinine in umol/L?eGFR in ml/min) compared with baseline, and between the intervention and control group at the end of the study (12 weeks)	Baseline,4weeks,8weeks,12weeks(End of Trial)
Secondary	Change of CRP	Change of CRP compared with baseline, and between the intervention and control group at the end of the study (12 weeks)	Baseline,4weeks,8weeks,12weeks(End of Trial)
Secondary	Change of Body mass index(BMI)	Change of Body mass index(BMI) compared with baseline, and between the intervention and control group at the end of the study (12 weeks)	Baseline,4weeks,8weeks,12weeks(End of Trial)
Secondary	Change of waist circumference	Change of waist circumference compared with baseline, and between the intervention and control group at the end of the study (12 weeks)	Baseline,4weeks,8weeks,12weeks(End of Trial)
Secondary	Change of hip circumference	Change of hip circumference compared with baseline, and between the intervention and control group at the end of the study (12 weeks)	Baseline,4weeks,8weeks,12weeks(End of Trial)
Secondary	Change of waist-to-hip ratio	Change of waist-to-hip ratio compared with baseline, and between the intervention and control group at the end of the study (12 weeks)	Baseline,4weeks,8weeks,12weeks(End of Trial)