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

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ClinicalTrials.gov Identifier: NCT03707171
Recruitment Status : Not yet recruiting
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Zhiming Zhu, Third Military Medical University

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.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Liraglutide Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Liraglutide on the Cognitive Function in Patients With Type 2 Diabetes Mellitus
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : February 1, 2019
Estimated Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arm Intervention/treatment
Active Comparator: Liraglutide
12 weeks of liraglutide treatment at adjusting dose, up to 1.8mg/day Drug: liraglutide
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 Comparator: Placebo
12 weeks of Placebo treatment at adjusting dose Drug:Placebo
Drug: placebo
Any hypoglycemic drugs except glucagon-like peptide type 1 (GLP-1) analogue.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707171


Locations
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China, Chongqing
The third hospital affiliated to the Third Military Medical University
Chongqing, Chongqing, China, 400042
Sponsors and Collaborators
Third Military Medical University

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Responsible Party: Zhiming Zhu, Director of the department of Hypertension & Endocrinology, Daping Hospital, Third Military Medical University
ClinicalTrials.gov Identifier: NCT03707171     History of Changes
Other Study ID Numbers: Liraglutide
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhiming Zhu, Third Military Medical University:
Type 2 diabetes mellitus
Cognitive function
Liraglutide

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists