Retinol-binding Protein 4 (RBP4) Metabolizm in Type 2 Diabetes Progression and Associated Cardiovascular Complications
RMTACC
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 26, 2020
CompletedFirst Posted
Study publicly available on registry
March 27, 2020
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2023
CompletedDecember 23, 2022
August 1, 2022
2.7 years
March 26, 2020
December 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
serum RBP4 level
serum RBP4 level in DM, pre-DM, CVD, DM-CVD and healthy controls.
2022.3
Study Arms (5)
RBP4 in diabetes
RBP4 in diagnosed diabetes.
RBP4 in pre-diabetes (pre-DM)
RBP4 in pre-diabetes (pre-DM).
RBP4 in DM-CVD
RBP4 in diabetic cardiovascular disease.
RBP4 in CVD
RBP4 in single coronary artery disease.
RBP4 in NC
RBP4 in healthy controls.
Interventions
Exposure factors，such as diet，exercise，environment
Eligibility Criteria
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.
You may qualify if:
- T2DM:
- Fasting plasma glucose (FPG)≥7.0 mmol/l;
- 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
- hPG 7.8-11.0 mmol/l
- HbA1c 5.7-6.4%.
You may not qualify if:
- type 1 diabetes
- liver or kidney disorders.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Biospecimen
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 were 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.The participants enrolled in the study provided written informed consent.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jing Sui, doctor
First Affiliated Hospital Xi'an Jiaotong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2020
First Posted
March 27, 2020
Study Start
April 1, 2020
Primary Completion
December 1, 2022
Study Completion
January 1, 2023
Last Updated
December 23, 2022
Record last verified: 2022-08