Using alpha-ketoglutarate to improve outcomes in patients with abdominal aortic aneurysms
The Intervention Effect Of Alpha-Ketoglutarate On Abdominal Aortic Aneurysm Progression and Rupture: A Prospective, Randomized Parallel Controlled Study Based On Large Cohorts
This study is testing if a nutritional supplement called alpha-ketoglutarate can help people with abdominal aortic aneurysms feel better and reduce the risk of their condition getting worse.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 300 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT04723888 on ClinicalTrials.gov |
What this trial studies
This project aims to determine if the nutritional supplement alpha-ketoglutarate can enhance outcomes for patients with abdominal aortic aneurysms (AAAs) measuring 39-49 mm in diameter. The study will involve oral administration of the supplement, which is known for its role in energy metabolism and is commonly used by athletes. Participants will be monitored for up to five years to assess the impact on AAA progression and rupture risk. The research seeks to establish a prediction model for AAA rupture risk in an elderly cohort.
Who should consider this trial
Good fit: Ideal candidates are Han nationality individuals aged 50 and older with an infrarenal AAA of 39-49 mm in diameter.
Not a fit: Patients with previous aortic surgery, known aortic dissection, or severe infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel method to slow the progression of abdominal aortic aneurysms and reduce the risk of rupture.
How similar studies have performed: While the use of alpha-ketoglutarate in this context is novel, its application in other metabolic and aging-related studies has shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Presence of an infrarenal AAA with a maximum diameter of 39-49 mm; 2. Han nationality; 3. Between 50 years or more, no gender limit; 4. No mental illness; 5. No history of supplement allergy or supplement allergy; 6. Subjects voluntarily participate in this study, sign an informed consent form, have good compliance, and cooperate with follow-up. Exclusion Criteria: 1. Previous infrarenal aortic surgery; 2. Planned major surgery; 3. Known aortic dissection; 4. Have received any other clinical trial treatment within 1 year; 5. Systemic treatment with corticosteroids or other systemic immunomodulatory therapy; 6. Severe infections, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.; 7. Known or suspected inherited connective tissue disorder; 8. Calculated creatinine clearance of less than 30 ml/min; 9. Known significant liver disease; 10. Known human immunodeficiency virus infection at the time of screening； 11. Serious concomitant illness associated with life expectancy of less than 2 years； 12. Any other significant and unstable condition that could limit compliance with the trial protocol.
Where this trial is running
Shanghai
- Cardiology, Ren Ji Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Jun Pu — RenJi Hospital
- Study coordinator: Jun Pu
- Email: pujun310@hotmail.com
- Phone: 86-21-68383477
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.