Trial · Interventional
CompletedPhase 3Registry dataChina
1 trial · 1 completed
Effects of Liraglutide on the Cognitive Function in Patients With Type 2 Diabetes Mellitus
NCT037071711 Oct 2018 to 1 May 2019
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Active comparator
Liraglutide
12 weeks of liraglutide treatment at adjusting dose, up to 1.8mg/day Drug: liraglutide
Placebo comparator
Placebo
12 weeks of Placebo treatment at adjusting dose Drug:Placebo
Outcomes the sponsor listed as primary.
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.
Changes of systolic blood pressure and diastolic blood pressure
Time frame · Baseline,4weeks,8weeks，12weeks(End of Trial)
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)
Change of fasting plasma glucose
Time frame · Baseline,4weeks,8weeks，12weeks(End of Trial)
Change of fasting plasma glucose compared with baseline, and between the intervention and control group at the end of the study (12 weeks)
Change of HbA1c
Time frame · Baseline,4weeks,8weeks，12weeks(End of Trial)
Change of HbA1c compared with baseline, and between the intervention and control group at the end of the study (12 weeks)
Change of lipid profile
Time frame · Baseline,4weeks,8weeks，12weeks(End of Trial)
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)
Change of liver enzymes
Time frame · Baseline,4weeks,8weeks，12weeks(End of Trial)
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)
Change of kidney function
Time frame · Baseline,4weeks,8weeks，12weeks(End of Trial)
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)
Change of CRP
Time frame · Baseline,4weeks,8weeks，12weeks(End of Trial)
Change of CRP compared with baseline, and between the intervention and control group at the end of the study (12 weeks)
Change of Body mass index(BMI)
Time frame · Baseline,4weeks,8weeks，12weeks(End of Trial)
Change of Body mass index(BMI) compared with baseline, and between the intervention and control group at the end of the study (12 weeks)
Change of waist circumference
Time frame · Baseline,4weeks,8weeks，12weeks(End of Trial)
Change of waist circumference compared with baseline, and between the intervention and control group at the end of the study (12 weeks)
Change of hip circumference
Time frame · Baseline,4weeks,8weeks，12weeks(End of Trial)
Change of hip circumference compared with baseline, and between the intervention and control group at the end of the study (12 weeks)
Change of waist-to-hip ratio
Time frame · Baseline,4weeks,8weeks，12weeks(End of Trial)
Change of waist-to-hip ratio compared with baseline, and between the intervention and control group at the end of the study (12 weeks)
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
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Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2021
Li et al. 2021Journal of the American Heart Associationcited by 68
PMID 34250817PMC8483500DOI 10.1161/jaha.120.020734PUB-34250817
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