Diabetes Mellitus, Type 2RMTACCNCT04325126
Retinol-binding Protein 4 (RBP4) Metabolizm in Type 2 Diabetes Progression and Associated Cardiovascular Complications
An observational study of Diabetes Mellitus, Type 2, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Exposure factors
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
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- 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%.
Who cannot join
- type 1 diabetes
- liver or kidney disorders.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Jing Sui, doctor, 0086-18991989230, suijing1029@163.com
About this study
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Exposure factors
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exposure factorsOther
Exposure factors，such as diet，exercise，environment
| Study group | Role | What they receive |
|---|---|---|
| RBP4 in diabetes | RBP4 in diagnosed diabetes. Receives: Other: Exposure factors | |
| RBP4 in pre-diabetes (pre-DM) | RBP4 in pre-diabetes (pre-DM). Receives: Other: Exposure factors | |
| RBP4 in DM-CVD | RBP4 in diabetic cardiovascular disease. Receives: Other: Exposure factors | |
| RBP4 in CVD | RBP4 in single coronary artery disease. Receives: Other: Exposure factors | |
| RBP4 in NC | RBP4 in healthy controls. Receives: Other: Exposure factors |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum RBP4 level
serum RBP4 level in DM, pre-DM, CVD, DM-CVD and healthy controls.
Measured: 2022.3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Apr 2020
- Primary completionDec 2022 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Sui, doctor, Study director, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325126
- Sponsor's protocol ID
- XJTU 2020 G-66
- Acronym
- RMTACC
- Status last verified
- Aug 2022
- First submitted
- 26 Mar 2020
- Last updated
- 23 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinol-binding Protein 4 (RBP4) Metabolizm in Type 2 Diabetes Progression and Associated Cardiovascular Complications
- ClinicalTrials.gov ID
- NCT04325126
- Acronym / sponsor ID
- RMTACC / XJTU 2020 G-66
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| RBP4 in diabetes | – | Other: Exposure factorsRBP4 in diagnosed diabetes. |
| RBP4 in pre-diabetes (pre-DM) | – | Other: Exposure factorsRBP4 in pre-diabetes (pre-DM). |
| RBP4 in DM-CVD | – | Other: Exposure factorsRBP4 in diabetic cardiovascular disease. |
| RBP4 in CVD | – | Other: Exposure factorsRBP4 in single coronary artery disease. |
| RBP4 in NC | – | Other: Exposure factorsRBP4 in healthy controls. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (2 listed)
- type 1 diabetes
- liver or kidney disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exposure factorsExposure factors，such as diet，exercise，environment | Other | RBP4 in CVD, RBP4 in DM-CVD, RBP4 in NC, RBP4 in diabetes, RBP4 in pre-diabetes (pre-DM) |
Primary outcome
serum RBP4 level
Time frame: 2022.3
serum RBP4 level in DM, pre-DM, CVD, DM-CVD and healthy controls.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Sui, doctor study director
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Sui, doctor (0086-18991989230, suijing1029@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum RBP4 level (time frame: 2022.3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2022.