Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2025-12-17 @ 1:59 AM
Study NCT ID:
NCT04723888
Status:
None
Last Update Posted:
2021-02-21 00:00:00
First Post:
2021-01-21 00:00:00
Brief Title:
Alpha-Ketoglutarate and Abdominal Aortic Aneurysm Progression and Rupture
Sponsor:
RenJi Hospital
Organization:
RenJi Hospital
Study Overview
Official Title:
The Intervention Effect Of Alpha-Ketoglutarate On Abdominal Aortic Aneurysm Progression and Rupture: A Prospective, Randomized Parallel Controlled Study Based On Large Cohorts
Status:
None
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None