Effects of Liraglutide on the Cognitive Function in Patients With Type 2 Diabetes Mellitus
Overview
- Phase
- Phase 3
- Intervention
- placebo
- Conditions
- Type 2 Diabetes Mellitus
- Sponsor
- Third Military Medical University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Changes of cognitive function assessed by cognitive function scale after 12 weeks.
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Zhiming Zhu
Director of the department of Hypertension & Endocrinology, Daping Hospital
Third Military Medical University
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.
Arms & Interventions
Placebo
12 weeks of Placebo treatment at adjusting dose Drug:Placebo
Intervention: placebo
Liraglutide
12 weeks of liraglutide treatment at adjusting dose, up to 1.8mg/day Drug: liraglutide
Intervention: Liraglutide
Outcomes
Primary Outcomes
Changes of cognitive function assessed by cognitive function scale after 12 weeks.
Time Frame: Baseline,4weeks,8weeks，12weeks(End of Trial)
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.
Secondary Outcomes
- Changes of systolic blood pressure and diastolic blood pressure(Baseline,4weeks,8weeks，12weeks(End of Trial))
- Change of fasting plasma glucose(Baseline,4weeks,8weeks，12weeks(End of Trial))
- Change of HbA1c(Baseline,4weeks,8weeks，12weeks(End of Trial))
- Change of lipid profile(Baseline,4weeks,8weeks，12weeks(End of Trial))
- Change of liver enzymes(Baseline,4weeks,8weeks，12weeks(End of Trial))
- Change of kidney function(Baseline,4weeks,8weeks，12weeks(End of Trial))
- Change of CRP(Baseline,4weeks,8weeks，12weeks(End of Trial))
- Change of Body mass index(BMI)(Baseline,4weeks,8weeks，12weeks(End of Trial))
- Change of waist circumference(Baseline,4weeks,8weeks，12weeks(End of Trial))
- Change of hip circumference(Baseline,4weeks,8weeks，12weeks(End of Trial))
- Change of waist-to-hip ratio(Baseline,4weeks,8weeks，12weeks(End of Trial))