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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03707171
Recruitment Status : Completed
First Posted : October 16, 2018
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Zhiming Zhu, Third Military Medical University

Tracking Information
First Submitted Date  ICMJE September 27, 2018
First Posted Date  ICMJE October 16, 2018
Last Update Posted Date July 10, 2019
Actual Study Start Date  ICMJE October 1, 2018
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Liraglutide on the Cognitive Function in Patients With Type 2 Diabetes Mellitus
Official Title  ICMJE Effects of Liraglutide on the Cognitive Function in Patients With Type 2 Diabetes Mellitus
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • 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.
  • Drug: placebo
    Any hypoglycemic drugs except glucagon-like peptide type 1 (GLP-1) analogue.
Study Arms  ICMJE
  • Active Comparator: Liraglutide
    12 weeks of liraglutide treatment at adjusting dose, up to 1.8mg/day Drug: liraglutide
    Intervention: Drug: Liraglutide
  • Placebo Comparator: Placebo
    12 weeks of Placebo treatment at adjusting dose Drug:Placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 1, 2019
Actual Primary Completion Date February 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03707171
Other Study ID Numbers  ICMJE Liraglutide
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhiming Zhu, Third Military Medical University
Study Sponsor  ICMJE Third Military Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Third Military Medical University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP