GLP-1 receptor agonists for diabetic cardiac autonomic neuropathy in type 2 diabetes
Official title: A Study on the Effect of GLP-1 Receptor Agonist (GLP-1RA) Intervention on Cardiac Autonomic Neuropathy in Patients With Type 2 Diabetes Mellitus
Run by The First Affiliated Hospital with Nanjing Medical University · NCT07558863 · Data updated 2026-11-12
This study will try once-weekly semaglutide or polyethylene glycol loxenatide plus usual care to see if they improve heart nerve function in adults with type 2 diabetes who have diabetic cardiac autonomic neuropathy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Status | Recruiting |
| Started | April 1, 2026 |
| Main results expected | March 30, 2028 |
| Study ends | August 30, 2028 |
| Registry record updated | April 30, 2026 |
| Trial ID | NCT07558863 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–70 with type 2 diabetes, BMI ≥24 kg/m², and evidence of diabetic cardiac autonomic neuropathy who can provide informed consent and attend study visits are ideal candidates.
✕Probably not a fit
Patients with arrhythmias or on heart-rate affecting medications, severe heart/liver/kidney dysfunction, thyroid disease, recent pancreatitis, or pregnant or lactating women are excluded and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized Phase 4 trial will enroll 60 adults with type 2 diabetes and diabetic cardiac autonomic neuropathy and randomize them to usual care or usual care plus a once-weekly GLP-1 receptor agonist (semaglutide or polyethylene glycol loxenatide) for 6 months. Participants undergo baseline and 6-month follow-up testing including blood tests, 24-hour heart rate variability monitoring, and cardiac autonomic reflex tests to quantify autonomic function. Key eligibility includes age 18–70 and BMI ≥24, while exclusion criteria include arrhythmias, use of rate-modifying drugs, severe organ dysfunction, thyroid disease, recent pancreatitis, pregnancy, or lactation. The trial compares changes in autonomic measures between groups to see if adding a GLP-1RA improves cardiac autonomic neuropathy beyond standard diabetes care.
Why it matters
Potential benefit: If effective, adding a GLP-1 receptor agonist could improve cardiac autonomic function, reduce symptoms like resting tachycardia and orthostatic hypotension, and potentially lower the risk of serious cardiac events in people with diabetic cardiac autonomic neuropathy.
How similar studies have gone: GLP-1 receptor agonists have demonstrated cardiovascular and metabolic benefits in other trials, but their specific effect on diabetic cardiac autonomic neuropathy is relatively untested and supported only by limited preliminary data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 18-70 years * Patients with type 2 diabetes mellitus (T2DM) who meet the diagnostic guidelines * Patient has signed the relevant informed consent form * Being overweight or obese (BMI ≥ 24 kg/m²) Exclusion Criteria: * Age \< 18 years * Pregnant or lactating women * Acute or chronic pancreatitis * Recent acute complications of diabetes (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state) * Arrhythmia or taking medications that affect heart rate (e.g., beta-blockers, non-dihydropyridine calcium channel blockers, antiarrhythmic drugs) * Thyroid disease * Severe organ dysfunction (e.g., heart, liver, kidney failure) * Denial of informed consent
Where it's running
-
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China Recruiting
Study contacts
- Study coordinator: jianbo Li
- Email: ljbzjlx18@aliyun.com
- Phone: 13115008178
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Effects of GLP-1RA on heart health in diabetes patients
This study is testing if a diabetes medication called Semaglutide can improve heart health and symptoms related to heart issues in people with type 2 diabetes.
-
Acute Blood Flow Restriction Walking in Type 2 Diabetes
This study tests whether adding blood flow restriction to treadmill walking affects immune cells in adults with type 2 diabetes.
-
Continuous Glucose Monitoring in Type 2 Diabetes Not on Insulin
This study tests whether using a continuous glucose monitoring system helps people with type 2 diabetes who aren’t using insulin to improve blood sugar control and quality of life.
-
Differentiating heart disease in autoimmune vs. type 2 diabetes
This study tests whether adult-onset autoimmune diabetes (AID/LADA) and type 2 diabetes (T2D) differ in how diabetic heart disease develops, using advanced heart imaging in people with AID, T2D, and healthy controls.
-
Lifestyle Metabotype Study B: Understanding Personalized Glucose Responses
This study tests how lifestyle, metabolism, and brain energy use relate to each person’s blood sugar response after meals, across people with and without prediabetes or type 2 diabetes.
-
Lifestyle Metabotype Study: How Daily Habits Shape Blood Sugar
This observational study tests whether personal lifestyle and biological factors can predict how a person’s blood sugar responds after meals.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.