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

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Exposure factors

• Registration Number: NCT04325126
• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-03-26
• Study First Posted: 2020-03-27
• Study Start: 2020-04-01
• Status Verified: 2022-08
• Primary Completion: 2022-12
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-23
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RBP4 in DM-CVD	Exposure factors	RBP4 in diabetic cardiovascular disease.
RBP4 in NC	Exposure factors	RBP4 in healthy controls.
RBP4 in CVD	Exposure factors	RBP4 in single coronary artery disease.
RBP4 in diabetes	Exposure factors	RBP4 in diagnosed diabetes.
RBP4 in pre-diabetes (pre-DM)	Exposure factors	RBP4 in pre-diabetes (pre-DM).

Primary Outcome Measures

Name	Time	Method
serum RBP4 level	2022.3	serum RBP4 level in DM, pre-DM, CVD, DM-CVD and healthy controls.

Trial Locations

Locations (1)

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China