Effects of GLP-1RA on heart health in diabetes patients
The Ameliorative Effects of GLP-1RA on Diabetic Cardiac Autonomatic Neuropathy
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.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (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 | NCT06461377 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of glucagon-like peptide-1 receptor agonist (GLP-1RA), specifically Semaglutide, on diabetic cardiac autonomic neuropathy (DCAN) in patients with type 2 diabetes. DCAN is a serious complication that can lead to severe cardiovascular issues and reduced survival rates. The trial aims to determine if GLP-1RA can improve heart rate variability and other symptoms associated with DCAN, addressing a gap in current diabetes management. Participants will be monitored for changes in their condition over the course of the intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a diagnosis of type 2 diabetes who are overweight or obese.
Not a fit: Patients under 18, pregnant or lactating women, and those with certain acute or chronic health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart health and quality of life for patients with type 2 diabetes suffering from autonomic neuropathy.
How similar studies have performed: While existing literature suggests GLP-1RA may improve other diabetic complications, studies specifically targeting DCAN are limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 18-70 years 2. Patients with T2DM who meet the diagnostic guidelines 3. The patient signed the relevant informed consent form 4. Being overweight or obese Exclusion Criteria: 1. \<18 years old 2. Pregnant or lactating women 3. Acute and chronic pancreatitis 4. Recent acute complications of diabetes 5. Arrhythmia or taking drugs that affect heart rate 6. Thyroid disease 7. Severe organ dysfunction 8. Denial of informed consen
Where this trial is running
Nanjing, Jiangsu
- the First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: jianbo Li, MD/PhD — First Affiliated Hospital，Nanjing Medical University，China
- Study coordinator: jianbo Li, MD/PhD
- Email: ljbzjlx18@aliyun.com
- Phone: 13951750648
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.