NCT03450837

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

February 15, 2018

Last Update Submit

February 28, 2018

Conditions

Keywords

Coronary artery disease; HDL; anabolic steroids

Outcome Measures

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.

    1 day

Secondary Outcomes (1)

  • Prevalence of CAD in young men anabolic steroids users

    1 day

Study Arms (3)

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 AngiographyDiagnostic 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 AngiographyDiagnostic 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 AngiographyDiagnostic Test: Macrophage cholesterol efflux mediated by HDL

Interventions

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.

Anabolic androgenic steroids nonusersAnabolic androgenic steroids usersSedentary control

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

Anabolic androgenic steroids nonusersAnabolic androgenic steroids usersSedentary control

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Maria Janieire NN Alves, MD

    Heart Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 15, 2018

First Posted

March 1, 2018

Study Start

April 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2017

Last Updated

March 1, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share