Diabetes Mellitus, Type 2NCT05659043
Glycation of apoA-I and Diabetic Atherogenesis
An observational study of Diabetes Mellitus, Type 2, run by Ruijin Hospital at 1 site in China.
Trial summary
The goal of this study is to determine the relationship of apoprotein A-1 (apoA-I) glycation and development of diabetic atherosclerosis. ApoA-I is crucial for reverse cholesterol transport and anti-inflammation/anti-atherosclersis functions of HDL. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- overnight fasting
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- Jan 2017to Dec 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is a single-center cohort study. Patients with type 2 diabetes and suspected coronary artery disease undergone coronary angiography at Ruijin Hospital, Shanghai, China are consecutively enrolled.
Who may be able to join
- Type 2 diabetes diagnosed by one of the following criteria:
- HbA1c >/= 6.5% Fasting plasma glucose >/= 7.0 mmol/l (confirmed) 2h plasma glucose value during OGTT >/= 11.1 mmol/l Already receiving glucose-lowering agents; Receiving coronary angiography for clinically suspected CAD (T2DM with CAD), Receiving CCTA for suspected CAD or other causes (T2DM without CAD).
Who cannot join
- Severe liver failure (Child-Pugh grade B to C)； Severe anemia (hemoglobin < 60g/L)； Familial hypercholesterolemia； Active malignant tumor； Active autoimmune diseases on corticosteroids； Acute or chronic infection； Death.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: The Impact of Glycation Modification of apoA-I on HDL Function and Atherogenesis in Type Diabetes Mellitus
The goal of this study is to determine the relationship of apoprotein A-1 (apoA-I) glycation and development of diabetic atherosclerosis.
ApoA-I is crucial for reverse cholesterol transport and anti-inflammation/anti-atherosclersis functions of HDL. However, apoA-I is easily subjected to non-enzymatic glycation modification in diabetic milleu. Our preliminary study has shown that apoA-I in HDL from type 2 diabetes mellitus (T2DM) patients with coronary artery disease (CAD) is significantly glycated, and site specific glycation of apoA-I impairs HDL function and is related to the development of atherosclerosis. To the best of our knowledge, less clinical information regarding apoA-I glycation and CAD has been reported. In this cross-sectional study, by consecutively enrolling diabetic patients with (two to three hundred) or without CAD (controls, six to eight hundred) in our hospital, we will isolate their serum HDL and perform a qualitative and quantitative proteomic analysis of apoA-I glycation. The relation of apoA-I glycation and HDL function and angiography-determined severity of CAD will be evaluated. Later, we will follow these diabetic patients to analyze the influence of apoA-I glycation on the outcome including plaque progression.
Read the detailed description
The goal of this study is to determine the relationship of apoprotein A-1 (apoA-I) glycation and development of diabetic atherosclerosis.
ApoA-I is crucial for reverse cholesterol transport and anti-inflammation/anti-atherosclersis functions of HDL. However, apoA-I is easily subjected to non-enzymatic glycation modification in diabetic milleu. Our preliminary study has shown that apoA-I in HDL from type 2 diabetes mellitus (T2DM) patients with coronary artery disease (CAD) is significantly glycated, and site specific glycation of apoA-I impairs HDL function and is related to the severity of atherosclerosis. To the best of our knowledge, less clinical information regarding apoA-I glycation and CAD has been reported. In this cross-sectional study, we will consecutively enroll several hundred diabetic patients (two to three hundred) with no CAD (less than stenosis of 25% in coronary CTA) as controls. And we will also consecutively enroll several hundred (six to eight hundred) angiographically established T2DM patients with CAD (stenosis of >50% in coronary angiography). Serum HDL of all participants will be isolated and a qualitative and quantitative proteomic analysis of apoA-I glycation will be performed by mass spectrometry. The relation of apoA-I glycaiton and HDL function and angioraphy-determined severity of CAD will be evaluated. Later, we will follow these diabetic patients for approximately two years to analyze the influence of apoA-I glycation on the clinical outcomes (stroke, myocardial infarction, hospitalization for heart failure, death due to cardiovascular causes, etc) including plaque progression.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- overnight fasting
- 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.
overnight fastingOther
All blood samples were taken on the day of cardiac catheterization after overnight fasting.
| Study group | Role | What they receive |
|---|---|---|
| T2DM with CAD | Diagnosis of T2DM was made according to the criteria of the American Diabetes Association. The patients were tested by angiography, with CAD diagnosed if luminal diameter narrowing was estimated visually at ≥50% in a major epicardial coronary artery. Receives: Other: overnight fasting | |
| T2DM without CAD | Diagnosis of T2DM was made according to the criteria of the American Diabetes Association. These subjects had no history of ischemic heart disease (acute myocardial infarction, unstable angina, chronic stable angina, previous percutaneous or surgical coronary revascularization, heart failure) and received CCTA in the outpatient clinics due to suspected CAD or other causes. And the luminal diameter narrowing was estimated by CCTA at ≤30%. Receives: Other: overnight fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative and Quantitative Mapping ApoA-I Glycation Modification Profiles
One of aims is understanding the importance of apoA-I glycation modification in HDL dysfunction and the progression of diabetic CAD, a comprehensive analysis of apoA-I glycation modification requires numerous levels of information, including (1) the type of glycation modification, (2) glycation localization, (3) glycation frequency in the subject cohort, and (4) the extent of glycation. The other aim is identifying the crucial pathogenic glycation sites of apoA-I based on apoA-I glycation modification profiles. Defining the chemistry of the pathologic glycation sites of apoA-I during progression of CAD will allow us to target specific epitopes using therapeutic antibodies or small molecules at every stage of disease.
Measured: completion date - December 2021
Secondary outcomes (1)
Individual ApoA-I Glycation Profiles Variability and Cardiovascular Events
Individual ApoA-I Glycation Profiles Variability is evaluated annually，and The incidence of MACCE (major adverse cardio and cerebral vascular events), lesion associated events (target lesion myocardial infarction, target lesion faliure, target vessel Revascularization, etc. observed continuously for 3 years.
Measured: December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study startJan 2017
- Primary completionDec 2021
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659043
- Sponsor's protocol ID
- 81870357
- Status last verified
- Dec 2022
- First submitted
- 11 Dec 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dai Y, Li Q, Ding F, Chen S, Li F, Gu R, Wang Q, Li L, Zhang J, Wang X, Chu C, Zheng Q, Shen Y, Chen Q, Liu J, Wang X, Peng Y, Zhuang S, Shen W, Pan M, Zhang R, Meng G, Zeng R, Lu L. Site-Specific Apo AI Glycation Impairs HDL Function and Promotes Atherosclerosis in Diabetes. Circulation. 2026 Aug 25. doi: 10.1161/CIRCULATIONAHA.125.078171. Online ahead of print.
PubMed 42639673
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Glycation Modification of apoA-I on HDL Function and Atherogenesis in Type Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05659043
- Acronym / sponsor ID
- 81870357
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Dec 2022 (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.
The goal of this study is to determine the relationship of apoprotein A-1 (apoA-I) glycation and development of diabetic atherosclerosis.
ApoA-I is crucial for reverse cholesterol transport and anti-inflammation/anti-atherosclersis functions of HDL. However, apoA-I is easily subjected to non-enzymatic glycation modification in diabetic milleu. Our preliminary study has shown that apoA-I in HDL from type 2 diabetes mellitus (T2DM) patients with coronary artery disease (CAD) is significantly glycated, and site specific glycation of apoA-I impairs HDL function and is related to the development of atherosclerosis. To the best of our knowledge, less clinical information regarding apoA-I glycation and CAD has been reported. In this cross-sectional study, by consecutively enrolling diabetic patients with (two to three hundred) or without CAD (controls, six to eight hundred) in our hospital, we will isolate their serum HDL and perform a qualitative and quantitative proteomic analysis of apoA-I glycation. The relation of apoA-I glycation and HDL function and angiography-determined severity of CAD will be evaluated. Later, we will follow these diabetic patients to analyze the influence of apoA-I glycation on the outcome including plaque progression.
Detailed description
The goal of this study is to determine the relationship of apoprotein A-1 (apoA-I) glycation and development of diabetic atherosclerosis.
ApoA-I is crucial for reverse cholesterol transport and anti-inflammation/anti-atherosclersis functions of HDL. However, apoA-I is easily subjected to non-enzymatic glycation modification in diabetic milleu. Our preliminary study has shown that apoA-I in HDL from type 2 diabetes mellitus (T2DM) patients with coronary artery disease (CAD) is significantly glycated, and site specific glycation of apoA-I impairs HDL function and is related to the severity of atherosclerosis. To the best of our knowledge, less clinical information regarding apoA-I glycation and CAD has been reported. In this cross-sectional study, we will consecutively enroll several hundred diabetic patients (two to three hundred) with no CAD (less than stenosis of 25% in coronary CTA) as controls. And we will also consecutively enroll several hundred (six to eight hundred) angiographically established T2DM patients with CAD (stenosis of >50% in coronary angiography). Serum HDL of all participants will be isolated and a qualitative and quantitative proteomic analysis of apoA-I glycation will be performed by mass spectrometry. The relation of apoA-I glycaiton and HDL function and angioraphy-determined severity of CAD will be evaluated. Later, we will follow these diabetic patients for approximately two years to analyze the influence of apoA-I glycation on the clinical outcomes (stroke, myocardial infarction, hospitalization for heart failure, death due to cardiovascular causes, etc) including plaque progression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T2DM with CAD | – | Other: overnight fastingDiagnosis of T2DM was made according to the criteria of the American Diabetes Association. The patients were tested by angiography, with CAD diagnosed if luminal diameter narrowing was estimated visually at ≥50% in a major epicardial coronary artery. |
| T2DM without CAD | – | Other: overnight fastingDiagnosis of T2DM was made according to the criteria of the American Diabetes Association. These subjects had no history of ischemic heart disease (acute myocardial infarction, unstable angina, chronic stable angina, previous percutaneous or surgical coronary revascularization, heart failure) and received CCTA in the outpatient clinics due to suspected CAD or other causes. And the luminal diameter narrowing was estimated by CCTA at ≤30%. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is a single-center cohort study. Patients with type 2 diabetes and suspected coronary artery disease undergone coronary angiography at Ruijin Hospital, Shanghai, China are consecutively enrolled.
Key inclusion criteria (2 listed)
- HbA1c >/= 6.5% Fasting plasma glucose >/= 7.0 mmol/l (confirmed) 2h plasma glucose value during OGTT >/= 11.1 mmol/l Already receiving glucose-lowering agents; Receiving coronary angiography for clinically suspected CAD (T2DM with CAD), Receiving CCTA for suspected CAD or other causes (T2DM without CAD).
Key exclusion criteria (1 listed)
- Severe liver failure (Child-Pugh grade B to C)； Severe anemia (hemoglobin < 60g/L)； Familial hypercholesterolemia； Active malignant tumor； Active autoimmune diseases on corticosteroids； Acute or chronic infection； Death.
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 |
|---|---|---|
| overnight fastingAll blood samples were taken on the day of cardiac catheterization after overnight fasting. | Other | T2DM with CAD, T2DM without CAD |
Primary outcome
Qualitative and Quantitative Mapping ApoA-I Glycation Modification Profiles
Time frame: completion date - December 2021
One of aims is understanding the importance of apoA-I glycation modification in HDL dysfunction and the progression of diabetic CAD, a comprehensive analysis of apoA-I glycation modification requires numerous levels of information, including (1) the type of glycation modification, (2) glycation localization, (3) glycation frequency in the subject cohort, and (4) the extent of glycation. The other aim is identifying the crucial pathogenic glycation sites of apoA-I based on apoA-I glycation modification profiles. Defining the chemistry of the pathologic glycation sites of apoA-I during progression of CAD will allow us to target specific epitopes using therapeutic antibodies or small molecules at every stage of disease.
1 secondary outcome
Individual ApoA-I Glycation Profiles Variability and Cardiovascular Events
Time frame: December 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Derived from this study: PubMed 42639673Dai Y, Li Q, Ding F, Chen S, Li F, Gu R, Wang Q, Li L, Zhang J, Wang X, Chu C, Zheng Q, Shen Y, Chen Q, Liu J, Wang X, Peng Y, Zhuang S, Shen W, Pan M, Zhang R, Meng G, Zeng R, Lu L. Site-Specific Apo AI Glycation Impairs HDL Function and Promotes Atherosclerosis in Diabetes. Circulation. 2026 Aug 25. doi: 10.1161/CIRCULATIONAHA.125.078171. Online ahead of print.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ruijin Hospital 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 2 inclusion and 1 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 21 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative and Quantitative Mapping ApoA-I Glycation Modification Profiles (time frame: completion date - December 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05659043, which also lists 1 linked publication.
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 21 Dec 2022.