Patients With an Abdominal Aortic Aneurysm of 39-49 mm in DiameterNCT04723888
Alpha-Ketoglutarate and Abdominal Aortic Aneurysm Progression and Rupture
A study testing alpha-ketoglutarate in people with Patients With an Abdominal Aortic Aneurysm of 39-49 mm in Diameter, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Patients With an Abdominal Aortic Aneurysm of 39-49 mm in Diameter
- What is being tested?
- alpha-ketoglutarate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2021to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of an infrarenal AAA with a maximum diameter of 39-49 mm;
- Han nationality;
- Between 50 years or more, no gender limit;
- No mental illness;
- No history of supplement allergy or supplement allergy;
- Subjects voluntarily participate in this study, sign an informed consent form, have good compliance, and cooperate with follow-up.
Who cannot join
- Previous infrarenal aortic surgery;
- Planned major surgery;
- Known aortic dissection;
- Have received any other clinical trial treatment within 1 year;
- Systemic treatment with corticosteroids or other systemic immunomodulatory therapy;
- Severe infections, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.;
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- Known or suspected inherited connective tissue disorder;
- Calculated creatinine clearance of less than 30 ml/min;
- Known significant liver disease;
- Known human immunodeficiency virus infection at the time of screening；
- Serious concomitant illness associated with life expectancy of less than 2 years；
- Any other significant and unstable condition that could limit compliance with the trial protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- Being tested
- alpha-ketoglutarate
- Keywords
- cohort study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alpha-ketoglutarateDietary supplement
alpha-ketoglutarate supplements
| Study group | Role | What they receive |
|---|---|---|
| alpha-ketoglutarate Group | Experimental | Take alpha-ketoglutarate supplements, alpha-ketoglutarate 300mg/d mixed with food or drink, for 1 years Receives: Dietary Supplement: alpha-ketoglutarate |
| Normal Control Group | No intervention | Don't take alpha-ketoglutarate supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
Rates of AAA repair/rupture
Calculate the incidence of AAA repair/rupture
Measured: 1 year
Rates of mortality
Calculate the mortality due to AAA rupture
Measured: 1 year
Changes level of plasma biomarker
Measure plasma levels of tryptase
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2021
- Study start1 Feb 2021
- Primary completion1 Feb 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With an Abdominal Aortic Aneurysm of 39-49 mm in DiameterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Pu, RenJi Hospital
- Investigators
- Jun Pu, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723888
- Sponsor's protocol ID
- AKG Intervention study
- Status last verified
- Feb 2021
- First submitted
- 21 Jan 2021
- Last updated
- 21 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04723888
- Acronym / sponsor ID
- AKG Intervention study
- Keywords
- cohort study
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| alpha-ketoglutarate Group | Experimental | Dietary Supplement: alpha-ketoglutarateTake 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presence of an infrarenal AAA with a maximum diameter of 39-49 mm;
- Han nationality;
- Between 50 years or more, no gender limit;
- No mental illness;
- No history of supplement allergy or supplement allergy;
Key exclusion criteria (12 listed)
- Previous infrarenal aortic surgery;
- Planned major surgery;
- Known aortic dissection;
- Have received any other clinical trial treatment within 1 year;
- Systemic treatment with corticosteroids or other systemic immunomodulatory therapy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alpha-ketoglutaratealpha-ketoglutarate supplements | Dietary supplement | alpha-ketoglutarate Group |
Primary outcome
Changes in aortic diameter
Time frame: 1 year
Measure the aortic diameter by ultrasound imaging from leading edge adventitia at the anterior wall to leading edge adventitia at the posterior wall.
3 secondary outcomes
Rates of AAA repair/rupture
Time frame: 1 year
Rates of mortality
Time frame: 1 year
Changes level of plasma biomarker
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Pu principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing alpha-ketoglutarate in people with Patients With an Abdominal Aortic Aneurysm of 39-49 mm in Diameter, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Pu (86-21-68383477, pujun310@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in aortic diameter (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.