Impaired HDL and Coronary Artery Disease in Anabolic Androgenic Steroid Users

Coronary Artery Disease Clinical Trial

Official title:

Diminished Macrophage Cholesterol Efflux Mediated by HDL and Coronary Artery Disease in Young Male Anabolic Androgenic Steroid Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03450837
• Other study ID #: CAD-AnabolicAndrogenicSteroids
• Status: Completed
• Phase: N/A
• First received: February 15, 2018
• Last updated: February 28, 2018
• Start date: April 1, 2015
• Est. completion date: April 1, 2017

Study information

• Verified date: February 2018
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Anabolic androgenic steroids (AASs) have been associated with coronary artery disease (CAD). The illicit use of these substances also leads to a remarkable decrease in high-density lipoprotein (HDL) plasma concentration, which could be a key factor in the atherosclerotic process. The investigators tested the functionality of HDL by cholesterol efflux and antioxidant capacity and its association with CAD in young men.

Description:

Twenty strength-trained AAS users (AASU) age 29±5 yr, 20 age-matched strength-trained AAS nonusers (AASNU), and 10 sedentary controls (SC) were enrolled.

HDL concentration and functionality by measuring the 14C-cholesterol efflux mediated by HDL and the ability of HDL in inhibiting LDL oxidation were evaluated.

Coronary artery was evaluated with coronary computed tomography angiography.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 1, 2017
• Est. primary completion date: April 1, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Anabolic androgenic steroids users and Anabolic androgenic steroids nonusers groups had been involved in strength training for at least 2 years;

• Anabolic androgenic steroids users should be self-administering anabolic androgenic steroids in periodic cycles lasting from 8 to 12 weeks for at least 2 years with 2-4 cycles per year;

• All anabolic androgenic steroids users were on a cycle over the course of the study;

• Sedentary control group: sedentary men without cardiovascular disease.

Exclusion Criteria:

• Smoking;

• Alcohol consumption;

• Use of diuretics and/or antihypertensive medications;

• Liver and kidney disease

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Diagnostic Test:
• Coronary Computed Tomography Angiography
To assess coronary artery plaque and calcification, all participants underwent coronary computed tomography angiography according to the guidelines of the Society of Cardiovascular Computed Tomography (SCCT). All CT scans were acquired in a 320-row detector scanner (AquillionOneTM - Toshiba Medical Systems Corporation, Otawara, Japan) with 0.5-mm thick slices. Acquisition protocol included coronary artery calcium scoring (CACS) and coronary CTA. CACS protocol utilized a 370-ms tube rotation, 120-kV tube voltage, 300-mA tube current, and 320x0.5-mm collimation with 3-mm slice thickness reconstructed images, one heart beat acquisition during diastole.
• Macrophage cholesterol efflux mediated by HDL
Macrophages were incubated with DMEM (Low Glucose, Gibco, Grand Island, New York, USA) containing 1 mg fatty acid free albumin (FAFA) (Sigma-Aldrich, Steinheim, Germany) plus 50 µg acetylated LDL/mL and 0.3 µCi 14C-cholesterol/mL (Amersham Biosciences, UK) for 48h. After washing with PBS/FAFA, cells were incubated in the presence or absence of HDL (50 µg/mL) for 8h. The amount of radioactivity present in the medium at the end of the HDL incubation period will indicate albumin-mediated cholesterol efflux with albumin alone and total efflux with albumin + HDL. Thus, specific HDL-mediated efflux will be calculated, subtracting the albumin-mediated efflux from total efflux

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration and the functionality of HDL	Blood sample was collected in the morning (between 8:00-10:00 a.m.) after 12 hours fasting and after 30 minutes of resting for HDL concentration assessment.; Determination of 14C-cholesterol efflux mediated by HDL utilized macrophages cultured cells from mice was used to test the functionality of HDL.	1 day
Secondary	Prevalence of CAD in young men anabolic steroids users	Coronary computed tomography angiography was used to evaluate coronary artery plaque and calcification.	1 day