Type 2 Diabetes MellitusNCT06573060
Glycemic Variability, Gut Microbiota, and Prognosis in T2DM With ACS
An observational study of Type 2 Diabetes Mellitus and Coronary Heart Disease, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
Patients with type 2 diabetes mellitus (T2DM) diagnosed with acute coronary syndrome (ACS) by coronary angiography in the Second Affiliated Hospital of Nanchang University were consecutively included in a prospective cohort study. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Coronary Heart Disease
- What is being tested?
- Continuous glucose monitoring
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 5 Jul 2023to 30 Sep 2025
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 120
Who may be able to join
- Clinical diagnosis of Type 2 Diabetes Mellitus (T2DM).
- Clinical diagnosis of Acute Coronary Syndrome (ACS).
Who cannot join
- History of hemodialysis.
- Recent antibiotic use within the past two weeks.
- Active malignant tumors.
- Pregnancy and breastfeeding.
- Inability to wear sensors due to severe skin conditions.
- Coagulation disorders, anemia, or abnormal hematocrit levels.
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- Requirement for MRI during the sensor-wearing period.
- Inability to follow study instructions or deemed unsuitable for the trial by the treating clinician/nurse.
- Inability to understand informed consent or communicate with researchers due to cognitive decline or mental illness.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital Of Nanchang University
Nanchang, Jiangxi, 330000
Yunfeng Shen, 18970819455, 1023744018@qq.com
Xiaojuan Jiao, 18970819455, syf92@live.com
About this study
Official title: Impact of Glycemic Variability and Gut Microbiota and Metabolites on the Prognosis of Patients With Type 2 Diabetes Mellitus Combined With Acute Coronary Syndrome
Patients with type 2 diabetes mellitus (T2DM) diagnosed with acute coronary syndrome (ACS) by coronary angiography in the Second Affiliated Hospital of Nanchang University were consecutively included in a prospective cohort study. During the acute phase of ACS, blood glucose was monitored using a continuous glucose monitoring system (CGM) for 14 days, and for patients who had been hospitalised for less than 14 days, they continued to wear the CGM for monitoring blood glucose until 14 days after discharge. During this period, stool and serum samples were analysed for multi-omics (16s rRNA sequencing and metabolomics). Subsequently, a follow-up period of at least 1 year was performed to observe the patients for the occurrence of adverse cardiovascular events (MACE) during the follow-up period and to assess the impact of glycaemic variability and gut flora and its metabolites on the prognosis of patients with T2DM combined with ACS.
- Conditions
- Type 2 Diabetes Mellitus, Coronary Heart Disease
- Being tested
- Continuous glucose monitoring
- Keywords
- gut microbiome, Type 2 Diabetes mellitus, coronary heart disease, glycemic variability
- Medical subject headings
- Diabetes Mellitus, Type 2, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoringDevice
Subjects with T2DM and acute coronary syndrome (n=120) were fitted with continuous glucose monitors (CGM) to closely monitor their blood glucose levels continuously for 14 days.
| Study group | Role | What they receive |
|---|---|---|
| ACS+T2DM | Patients with Type 2 Diabetes Mellitus (T2DM) diagnosed with Acute Coronary Syndrome (ACS) through coronary angiography. Receives: Device: Continuous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
Composite Major Adverse Cardiovascular Events (MACE)
Measured: 2023.7-2025.10
Secondary outcomes (5)
cardiovascular mortality
Deaths due to heart and/or vascular disease. According to the World Health Organisation (WHO) classification, cardiovascular diseases include a wide range of diseases such as coronary heart disease, myocardial infarction, stroke and hypertension.
Measured: 2023.7-2025.10
ACS Recurrence
Refers to the recurrence of a new ACS event after an episode of ACS. Depending on the signs and symptoms, patients can be classified as having STEMI, NSTEMI, or unstable angina.
Measured: 2023.7-2025.10
Angina requiring revascularisation
Presence of indications for coronary revascularisation
Measured: 2023.7-2025.10
Acute decompensated heart failure requiring hospitalisation
Clinical syndrome caused by acute imbalance of oxygen supply and demand due to impaired cardiac function, manifested by dyspnoea, pulmonary oedema and peripheral oedema. The patient's condition is severe enough to require hospitalisation.
Measured: 2023.7-2025.10
Strokes requiring hospitalisation
An acute disease with sudden defects in brain function, such as sudden motor, sensory, speech, and vision disorders. The patient's condition is serious enough to require hospitalisation for treatment and observation.
Measured: 2023.7-2025.10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start5 Jul 2023
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang 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
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaojuan Jiao, Principal investigator, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573060
- Sponsor's protocol ID
- DMACS20240719
- Status last verified
- Aug 2023
- First submitted
- 1 Aug 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy and confidentiality issues: Participants' data may contain sensitive personal information. Sharing this data could lead to privacy breaches, violating data protection regulations (such as GDPR).
Publications
Kosiborod M, Rathore SS, Inzucchi SE, Masoudi FA, Wang Y, Havranek EP, Krumholz HM. Admission glucose and mortality in elderly patients hospitalized with acute myocardial infarction: implications for patients with and without recognized diabetes. Circulation. 2005 Jun 14;111(23):3078-86. doi: 10.1161/CIRCULATIONAHA.104.517839. Epub 2005 Jun 6.
PubMed 15939812Emerging Risk Factors Collaboration; Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010 Jun 26;375(9733):2215-22. doi: 10.1016/S0140-6736(10)60484-9.
PubMed 20609967
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Glycemic Variability and Gut Microbiota and Metabolites on the Prognosis of Patients With Type 2 Diabetes Mellitus Combined With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT06573060
- Acronym / sponsor ID
- DMACS20240719
- Conditions
- Type 2 Diabetes Mellitus, Coronary Heart Disease
- Keywords
- gut microbiome, Type 2 Diabetes mellitus, coronary heart disease, glycemic variability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 27 Aug 2024 (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.
Patients with type 2 diabetes mellitus (T2DM) diagnosed with acute coronary syndrome (ACS) by coronary angiography in the Second Affiliated Hospital of Nanchang University were consecutively included in a prospective cohort study. During the acute phase of ACS, blood glucose was monitored using a continuous glucose monitoring system (CGM) for 14 days, and for patients who had been hospitalised for less than 14 days, they continued to wear the CGM for monitoring blood glucose until 14 days after discharge. During this period, stool and serum samples were analysed for multi-omics (16s rRNA sequencing and metabolomics). Subsequently, a follow-up period of at least 1 year was performed to observe the patients for the occurrence of adverse cardiovascular events (MACE) during the follow-up period and to assess the impact of glycaemic variability and gut flora and its metabolites on the prognosis of patients with T2DM combined with ACS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACS+T2DM | – | Device: Continuous glucose monitoringPatients with Type 2 Diabetes Mellitus (T2DM) diagnosed with Acute Coronary Syndrome (ACS) through coronary angiography. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 120
Key inclusion criteria (2 listed)
- Clinical diagnosis of Type 2 Diabetes Mellitus (T2DM).
- Clinical diagnosis of Acute Coronary Syndrome (ACS).
Key exclusion criteria (9 listed)
- History of hemodialysis.
- Recent antibiotic use within the past two weeks.
- Active malignant tumors.
- Pregnancy and breastfeeding.
- Inability to wear sensors due to severe skin conditions.
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 |
|---|---|---|
| Continuous glucose monitoringSubjects with T2DM and acute coronary syndrome (n=120) were fitted with continuous glucose monitors (CGM) to closely monitor their blood glucose levels continuously for 14 days. | Device | ACS+T2DM |
Primary outcome
Major adverse cardiovascular events
Time frame: 2023.7-2025.10
Composite Major Adverse Cardiovascular Events (MACE)
5 secondary outcomes
cardiovascular mortality
Time frame: 2023.7-2025.10
ACS Recurrence
Time frame: 2023.7-2025.10
Angina requiring revascularisation
Time frame: 2023.7-2025.10
Acute decompensated heart failure requiring hospitalisation
Time frame: 2023.7-2025.10
Strokes requiring hospitalisation
Time frame: 2023.7-2025.10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
- Background: PubMed 15939812Kosiborod M, Rathore SS, Inzucchi SE, Masoudi FA, Wang Y, Havranek EP, Krumholz HM. Admission glucose and mortality in elderly patients hospitalized with acute myocardial infarction: implications for patients with and without recognized diabetes. Circulation. 2005 Jun 14;111(23):3078-86. doi: 10.1161/CIRCULATIONAHA.104.517839. Epub 2005 Jun 6.
- Background: PubMed 20609967Emerging Risk Factors Collaboration; Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010 Jun 26;375(9733):2215-22. doi: 10.1016/S0140-6736(10)60484-9.
- Individual participant dataSharing planned: No. Privacy and confidentiality issues: Participants' data may contain sensitive personal information. Sharing this data could lead to privacy breaches, violating data protection regulations (such as GDPR).
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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.
Xiaojuan Jiao principal investigator
Second Affiliated Hospital of Nanchang 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 Type 2 Diabetes Mellitus and Coronary Heart Disease, run by Second Affiliated Hospital of Nanchang 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 2 inclusion and 9 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 27 Aug 2024. 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 YunFeng Shen, PhD degree (+8618970819455, syf92@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiovascular events (time frame: 2023.7-2025.10). 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 NCT06573060, which also lists 2 linked publications.
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 27 Aug 2024.