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

Sponsor
First Affiliated Hospital Xi'an Jiaotong University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04325126
Collaborator
(none)
500
1
23
21.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exposure factors

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 Design

Study Type:
Observational
Anticipated Enrollment :
500 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Retinol-binding Protein 4 (RBP4) Metabolizm in Type 2 Diabetes Progression and Associated Cardiovascular Complications
Actual Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. serum RBP4 level [2022.3]

    serum RBP4 level in DM, pre-DM, CVD, DM-CVD and healthy controls.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi China 710061

Sponsors and Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier:
NCT04325126
Other Study ID Numbers:
  • XJTU 2020 G-66
First Posted:
Mar 27, 2020
Last Update Posted:
Aug 27, 2021
Last Verified:
Aug 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 27, 2021