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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| alpha-ketoglutarate Group | Experimental | Take alpha-ketoglutarate supplements, alpha-ketoglutarate 300mg/d mixed with food or drink, for 1 years |
|
| Normal Control Group | No Intervention | Don't take alpha-ketoglutarate supplements |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alpha-ketoglutarate | Dietary Supplement | alpha-ketoglutarate supplements |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in aortic diameter | Measure the aortic diameter by ultrasound imaging from leading edge adventitia at the anterior wall to leading edge adventitia at the posterior wall. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of AAA repair/rupture | Calculate the incidence of AAA repair/rupture | 1 year |
| Rates of mortality | Calculate the mortality due to AAA rupture |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jun Pu | Contact | 86-21-68383477 | pujun310@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jun Pu | RenJi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiology, Ren Ji Hospital | Recruiting | Shanghai | China |
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| ID | Term |
|---|---|
| D007656 | Ketoglutaric Acids |
| ID | Term |
|---|---|
| D005977 | Glutarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| 1 year |
| Changes level of plasma biomarker | Measure plasma levels of tryptase | 1 year |
| D009930 |
| Organic Chemicals |
| D007651 | Keto Acids |