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

NCT03707171 | Completed Phase 3

• 1 other identifier: Liraglutide
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 diabetes mellitus; Cognitive function; Liraglutide

Outcome Measures

Primary Outcomes (1)

• Changes of cognitive function assessed by cognitive function scale after 12 weeks.

  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.

  Baseline,4weeks,8weeks，12weeks(End of Trial)

Secondary Outcomes (11)

• 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)

Study Arms (2)

Liraglutide

ACTIVE COMPARATOR

12 weeks of liraglutide treatment at adjusting dose, up to 1.8mg/day Drug: liraglutide

Drug: Liraglutide

Placebo

PLACEBO COMPARATOR

12 weeks of Placebo treatment at adjusting dose Drug:Placebo

Drug: placebo

Interventions

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.

Liraglutide

placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes。

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

The third hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Related Publications (1)

• Li Q, Jia M, Yan Z, Li Q, Sun F, He C, Li Y, Zhou X, Zhang H, Liu X, Bu X, Gao P, He H, Zhao Z, Zhu Z. Activation of Glucagon-Like Peptide-1 Receptor Ameliorates Cognitive Decline in Type 2 Diabetes Mellitus Through a Metabolism-Independent Pathway. J Am Heart Assoc. 2021 Jul 20;10(14):e020734. doi: 10.1161/JAHA.120.020734. Epub 2021 Jul 10.

  PMID: 34250817 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the department of Hypertension & Endocrinology, Daping Hospital

Study Record Dates

• First Submitted: September 27, 2018
• First Posted: October 16, 2018
• Study Start: October 1, 2018
• Primary Completion: February 1, 2019
• Study Completion: May 1, 2019
• Last Updated: July 10, 2019

Record last verified: 2019-07

Locations

CN (1)