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

December 21, 2022 updated by: First Affiliated Hospital Xi'an Jiaotong University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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. The different groups were matched for age, sex and BMI.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
RBP4 in diabetes
RBP4 in diagnosed diabetes.
Other: Exposure factors
Exposure factors，such as diet，exercise，environment
RBP4 in pre-diabetes (pre-DM)
RBP4 in pre-diabetes (pre-DM).
Other: Exposure factors
Exposure factors，such as diet，exercise，environment
RBP4 in DM-CVD
RBP4 in diabetic cardiovascular disease.
Other: Exposure factors
Exposure factors，such as diet，exercise，environment
RBP4 in CVD
RBP4 in single coronary artery disease.
Other: Exposure factors
Exposure factors，such as diet，exercise，environment
RBP4 in NC
RBP4 in healthy controls.
Other: Exposure factors
Exposure factors，such as diet，exercise，environment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum RBP4 level
Time Frame: 2022.3
serum RBP4 level in DM, pre-DM, CVD, DM-CVD and healthy controls.
2022.3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Investigators

  • Study Director: Jing Sui, doctor, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

January 1, 2023

Study Registration Dates

First Submitted

March 26, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 27, 2020

Study Record Updates

Last Update Posted (Actual)

December 23, 2022

Last Update Submitted That Met QC Criteria

December 21, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU 2020 G-66

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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