Examining the link between blood sugar levels, gut bacteria, and heart health in diabetes patients
Impact of Glycemic Variability and Gut Microbiota and Metabolites on the Prognosis of Patients With Type 2 Diabetes Mellitus Combined With Acute Coronary Syndrome
This study is testing how changes in blood sugar and gut bacteria might affect heart health in people with type 2 diabetes who have had a heart issue.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Nanchang University Academic / other |
| Locations | 1 site (Nanchang, Jiangxi) |
| Trial ID | NCT06573060 on ClinicalTrials.gov |
What this trial studies
This observational study involves patients with type 2 diabetes mellitus (T2DM) who have been diagnosed with acute coronary syndrome (ACS). Participants will undergo continuous glucose monitoring for 14 days, during which blood glucose levels will be tracked, and stool and serum samples will be collected for multi-omics analysis. The study aims to assess the relationship between glycemic variability, gut microbiota, and the prognosis of patients over a follow-up period of at least one year, focusing on the occurrence of major adverse cardiovascular events (MACE).
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with both type 2 diabetes mellitus and acute coronary syndrome.
Not a fit: Patients with recent antibiotic use, active malignancies, or severe skin conditions that prevent sensor use may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how managing blood sugar levels and gut health may improve heart health outcomes for diabetes patients.
How similar studies have performed: While the specific combination of glycemic variability, gut microbiota, and cardiovascular outcomes in this context may be novel, related studies have shown promising results in understanding the role of gut health in diabetes management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Clinical diagnosis of Type 2 Diabetes Mellitus (T2DM). Clinical diagnosis of Acute Coronary Syndrome (ACS). Exclusion Criteria: 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. 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.
Where this trial is running
Nanchang, Jiangxi
- The Second Affiliated Hospital Of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
Study contacts
- Principal investigator: Xiaojuan Jiao — Second Affiliated Hospital of Nanchang University
- Study coordinator: YunFeng Shen, PhD degree
- Email: syf92@live.com
- Phone: +8618970819455
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.