CClinicalTrials.gg
CompletedNCT03450837Updated Mar 1, 2018

Impaired HDL and Coronary Artery Disease in Anabolic Androgenic Steroid Users

An observational study in Coronary Artery Disease, sponsored by University of Sao Paulo General Hospital. Completed. Open to male participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-01.

Sponsored by University of Sao Paulo General Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
51
Ages
18 Years to 45 Years
Sex
Male
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Coronary Artery Disease

Keywords

  • Coronary artery disease; HDL; anabolic steroids
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Anabolic androgenic steroids users and nonusers were recreational weightlifters or amateur bodybuilding athletes who were recruited from gymnasiums.

Sedentary control group was recruited from community sample.

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

Exclusion Criteria:

  • Smoking;
  • Alcohol consumption;
  • Use of diuretics and/or antihypertensive medications;
  • Liver and kidney disease
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
51 participants (actual)
Patient registry
No

Groups and cohorts

  • Anabolic androgenic steroids users

    This group had been involved in strength training for at least 2 years, 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 participants were on a cycle over the course of the study. Coronary Computed Tomography Angiography and Macrophage cholesterol efflux mediated by HDL

    Diagnostic Test: Coronary Computed Tomography Angiography · Diagnostic Test: Macrophage cholesterol efflux mediated by HDL

  • Anabolic androgenic steroids nonusers

    This group had been involved in strength training for at least 2 years and they have never took anabolic androgenic steroids. Coronary Computed Tomography Angiography and Macrophage cholesterol efflux mediated by HDL

    Diagnostic Test: Coronary Computed Tomography Angiography · Diagnostic Test: Macrophage cholesterol efflux mediated by HDL

  • Sedentary control

    This group were sedentary men without cardiovascular disease. Coronary Computed Tomography Angiography and Macrophage cholesterol efflux mediated by HDL

    Diagnostic Test: Coronary Computed Tomography Angiography · Diagnostic Test: Macrophage cholesterol efflux mediated by HDL

Interventions

  • Diagnostic testCoronary 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.

  • Diagnostic testMacrophage 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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 day

Secondary outcomes

  1. Prevalence of CAD in young men anabolic steroids users

    Coronary computed tomography angiography was used to evaluate coronary artery plaque and calcification.

    Time frame: 1 day

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03450837
Lead sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
Responsible party
Maria Janieire de Nazaré Nunes Alves (PhD, University of Sao Paulo General Hospital) — Principal investigator
First posted
Mar 1, 2018
Start date
Apr 1, 2015
Primary completion
Apr 1, 2016
Completion
Apr 1, 2017
Last update
Mar 1, 2018

Study contacts

Maria Janieire NN Alves, MD
principal investigator · Heart Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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