NCT04723888

Alpha-Ketoglutarate and Abdominal Aortic Aneurysm Progression and Rupture

The Intervention Effect Of Alpha-Ketoglutarate On Abdominal Aortic Aneurysm Progression and Rupture: A Prospective, Randomized Parallel Controlled Study Based On Large Cohorts

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Abdominal aortic aneurysm (AAA) is an age-related disease that characterized by permanent regional dilation of the abdominal aortae, which results in catastrophic event of rupture and sudden death. Currently, no effective drug to limit the progression or reduce the risk of rupture has been developed. Metabolic pathways, including glucose metabolism, lipid metabolism, and amino acid metabolism, have indispensable roles in normal and dysfunctional vasculature. The Krebs cycle is responsible for obtaining energy from food in the form of ATP, and ATP is essential for muscle contraction and correct functioning of all organs. Besides, tight control of mitochondrial functions is critical for maintaining metabolism balance. As an important metabolite in Krebs cycle, alpha-ketoglutarate not only improved energy metabolism, but also extended lifespan and reduced morbidity in aging mice. It is widely used in the market as a nutritional supplement specially by athletes to increase muscle strength. Until now, no obvious toxic and side effects to the body was observed. Given the high bioavailability, we propose that dietary supplementation with alpha-ketoglutarate can improve the outcome in patients with an abdominal aortic aneurysm of 39-49 mm in diameter. Therefore, the project team intends to establish the abdominal aortic aneurysm rupture risk prediction model in the elderly cohort in the early stage, and randomize groups in patients with an abdominal aortic aneurysm of 39-49 mm in diameter based on whether or not to supplement alpha-ketoglutarate. There are two cohorts: the alpha-ketoglutarate intervention cohort and the parallel control cohort. By observing the efficacy in terms of change in aortic diameter and abdominal aortic aneurysm rupture incidence in the two groups during the follow-up period, it provides evidence-based medical evidence for the future clinical application of alpha-ketoglutarate.

Conditions

• Patients With an Abdominal Aortic Aneurysm of 39-49 mm in Diameter

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	alpha-ketoglutarate	alpha-ketoglutarate supplements

Timeline

• Start date: 2021-02-01
• Primary completion: 2026-02-01
• Completion: 2026-12-31
• First posted: 2021-01-26
• Last updated: 2021-02-21

Locations

1 site across 1 country: China