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NCT Number: NCT03707171

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The third hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

liraglutide

Drug

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

Drug

Any hypoglycemic drugs except glucagon-like peptide type 1 (GLP-1) analogue.

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 16, 2018
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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