Retinol-binding Protein 4 (RBP4) Metabolizm in Type 2 Diabetes Progression and Associated Cardiovascular Complications

NCT ID: NCT04325126

Last Updated: 2022-12-23

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

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2023-01-31

Brief Summary

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Retinol-binding protein 4 (RBP4) may affects obesity development and the development of obesity-related diseases including insulin resistance, type 2 diabetes, steatohepatitis and cardiovascular disease. This study aims to examine the involvement of RBP4 in patients with diagnosed diabetes, diabetic cardiovascular disease, pre-diabetes (pre-DM) and healthy controls during the progression of T2DM, and to evaluate the ability of RBP4 to predict cases of diabetes with an elevated risk of cardiovascular complications . Along with animal experiment.

Detailed Description

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A total of 500 Chinese patients admitted to the First Affliated Hospital of Xi'an Jiaotong University (Xi'an, China) between March 2020 and March 2022 were recruited to investigate the RBP4 profles. Peripheral blood samples are drawn at the initial medical examination, in the morning after a fast of at least 8 h, and immediately stored at -80˚C until the sphingolipid measurements were performed.

Blood pressure, WC, hip circumference (HC), body weight and body height were measured by a trained physician. The participants enrolled in the study provided written informed consent.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RBP4 in diabetes

RBP4 in diagnosed diabetes.

Exposure factors

Intervention Type OTHER

Exposure factors,such as diet,exercise,environment

RBP4 in pre-diabetes (pre-DM)

RBP4 in pre-diabetes (pre-DM).

Exposure factors

Intervention Type OTHER

Exposure factors,such as diet,exercise,environment

RBP4 in DM-CVD

RBP4 in diabetic cardiovascular disease.

Exposure factors

Intervention Type OTHER

Exposure factors,such as diet,exercise,environment

RBP4 in CVD

RBP4 in single coronary artery disease.

Exposure factors

Intervention Type OTHER

Exposure factors,such as diet,exercise,environment

RBP4 in NC

RBP4 in healthy controls.

Exposure factors

Intervention Type OTHER

Exposure factors,such as diet,exercise,environment

Interventions

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Exposure factors

Exposure factors,such as diet,exercise,environment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

T2DM:

* Fasting plasma glucose (FPG)≥7.0 mmol/l;
* 2 h plasma glucose (2hPG) ≥11.1 mmol/l;
* glycated hemoglobin (HbA1c) level ≥6.5%;
* random plasma glucose ≥11.1 mmol/l plus symptoms of hyperglycemia;
* T2DM diagnosed previously.

Pre-DM was defned as follows:

* FPG ≥5.6-6.9 mmol/l
* 2hPG 7.8-11.0 mmol/l
* HbA1c 5.7-6.4%.

Exclusion Criteria

* type 1 diabetes
* liver or kidney disorders.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jing Sui, doctor

Role: STUDY_DIRECTOR

First Affiliated Hospital Xi'an Jiaotong University

Locations

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The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jing Sui, doctor

Role: CONTACT

Phone: 0086-18991989230

Email: [email protected]

Jing Sui, doctor

Role: CONTACT

Phone: 0086-029-85324771

Email: [email protected]

Facility Contacts

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Jing Sui, doctor

Role: primary

Other Identifiers

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XJTU 2020 G-66

Identifier Type: -

Identifier Source: org_study_id