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

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Xi'an Jiaotong University

Status

Enrolling

Conditions

Diabetes Mellitus, Type 2

Treatments

Other: Exposure factors

Study type

Observational

Funder types

Other

Identifiers

NCT04325126
XJTU 2020 G-66

Details and patient eligibility

About

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.

Full 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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

500 participants in 5 patient groups

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

Trial contacts and locations

1

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Central trial contact

Jing Sui, doctor; Jing Sui, doctor

Data sourced from clinicaltrials.gov

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