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

NCT ID: NCT03707171

Last Updated: 2019-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-01

Study Completion Date

2019-05-01

Brief Summary

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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

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liraglutide

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

Group Type ACTIVE_COMPARATOR

Liraglutide

Intervention Type 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

12 weeks of Placebo treatment at adjusting dose Drug:Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Military Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zhiming Zhu

Director of the department of Hypertension & Endocrinology, Daping Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The third hospital affiliated to the Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 34250817 (View on PubMed)

Other Identifiers

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Liraglutide

Identifier Type: -

Identifier Source: org_study_id

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