Alpha-Ketoglutarate and Abdominal Aortic Aneurysm Progression and Rupture

NCT04723888 | Recruiting

• 1 other identifier: AKG Intervention study
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

cohort study

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Rates of AAA repair/rupture

  1 year

• Rates of mortality

  1 year

• Changes level of plasma biomarker

  1 year

Study Arms (2)

alpha-ketoglutarate Group

EXPERIMENTAL

Take alpha-ketoglutarate supplements, alpha-ketoglutarate 300mg/d mixed with food or drink, for 1 years

Dietary Supplement: alpha-ketoglutarate

Normal Control Group

NO INTERVENTION

Don't take alpha-ketoglutarate supplements

Interventions

alpha-ketoglutarate DIETARY_SUPPLEMENT

alpha-ketoglutarate supplements

alpha-ketoglutarate Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.;
• 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.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Cardiology, Ren Ji Hospital

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Ketoglutaric Acids

Intervention Hierarchy (Ancestors)

Glutarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Keto Acids

Study Officials

• Jun Pu

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Pu

CONTACT

86-21-68383477; pujun310@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiovascular Medicine

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: February 1, 2021
• Primary Completion: February 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)