NCT04723888 Alpha-Ketoglutarate and Abdominal Aortic Aneurysm Progression and Rupture
| NCT ID | NCT04723888 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RenJi Hospital |
| Condition | Patients With an Abdominal Aortic Aneurysm of 39-49 mm in Diameter |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2021-02-01 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2021-02-01 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this project is to define whether nutritional supplement (oral administration with alpha-ketoglutarate) capable of filling-up the citric acid cycle (anaplerotic therapy) can improve outcomes in patients with an abdominal aortic aneurysm of 39-49 mm in diameter on ultrasound imaging. Alpha-ketoglutarate is commonly used as a nutritional supplement specially by athletes to increase muscle strength. They can be mixed with formula or other foods. Subjects will be followed for up to 5 years.
Eligibility 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.
Contact & Investigator
Jun Pu
PRINCIPAL INVESTIGATOR
RenJi Hospital
Frequently Asked Questions
Who can join the NCT04723888 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Patients With an Abdominal Aortic Aneurysm of 39-49 mm in Diameter. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04723888 currently recruiting?
Yes, NCT04723888 is actively recruiting participants. Contact the research team at pujun310@hotmail.com for enrollment information.
Where is the NCT04723888 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT04723888 clinical trial?
NCT04723888 is sponsored by RenJi Hospital. The principal investigator is Jun Pu at RenJi Hospital. The trial plans to enroll 300 participants.