GLP-1 receptor agonists for diabetic cardiac autonomic neuropathy in type 2 diabetes
A Study on the Effect of GLP-1 Receptor Agonist (GLP-1RA) Intervention on Cardiac Autonomic Neuropathy in Patients With Type 2 Diabetes Mellitus
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 |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07558863 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nanjing, Jiangsu
- the First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: jianbo Li
- Email: ljbzjlx18@aliyun.com
- Phone: 13115008178
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.