- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04325126
Retinol-binding Protein 4 (RBP4) Metabolizm in Type 2 Diabetes Progression and Associated Cardiovascular Complications (RMTACC)
Study Overview
Status
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Jing Sui, doctor
- Phone Number: 0086-029-85324771
- Email: suijing1029@163.com
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710061
- Recruiting
- The First Affiliated Hospital of Xi'an Jiaotong University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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.
|
Exposure factors,such as diet,exercise,environment
|
RBP4 in pre-diabetes (pre-DM)
RBP4 in pre-diabetes (pre-DM).
|
Exposure factors,such as diet,exercise,environment
|
RBP4 in DM-CVD
RBP4 in diabetic cardiovascular disease.
|
Exposure factors,such as diet,exercise,environment
|
RBP4 in CVD
RBP4 in single coronary artery disease.
|
Exposure factors,such as diet,exercise,environment
|
RBP4 in NC
RBP4 in healthy controls.
|
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
Investigators
- Study Director: Jing Sui, doctor, First Affiliated Hospital Xi'an Jiaotong University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
AstraZenecaRecruiting
Clinical Trials on Exposure factors
-
Qilu Hospital of Shandong UniversityNot yet recruiting
-
Radboud University Medical CenterSint MaartenskliniekCompletedPsoriasis | Psoriasis Vulgaris | Psoriatic Arthritis | Psoriatic NailNetherlands
-
Qilu Hospital of Shandong UniversityFirst Affiliated Hospital Xi'an Jiaotong University; First Affiliated Hospital... and other collaboratorsNot yet recruiting
-
Charite University, Berlin, GermanyThe Federal Office for Radiation Protection, Germany; Seibersdorf Labor GmbHCompleted
-
Emory UniversityCenters for Disease Control and PreventionWithdrawnPost Traumatic Stress Disorder, PTSD
-
University of WyomingUnknown
-
University of Missouri-ColumbiaCompletedType 2 DiabetesUnited States
-
Red Maple Trials Inc.Ottawa Allergy Research CorporationCompletedAllergic Rhinitis | Rhinoconjunctivitis | ExposureCanada
-
University of BolognaUnknownIntrahepatic CholangiocarcinomaItaly
-
Uppsala UniversityRecruiting