Coronary Artery DiseaseNCT03450837
Impaired HDL and Coronary Artery Disease in Anabolic Androgenic Steroid Users
An observational study of Coronary Artery Disease, run by University of Sao Paulo General Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Coronary Computed Tomography Angiography and Macrophage cholesterol efflux mediated by HDL
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2015to 1 Apr 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Smoking;
- Alcohol consumption;
- Use of diuretics and/or antihypertensive medications;
- Liver and kidney disease
About this study
Official title: Diminished Macrophage Cholesterol Efflux Mediated by HDL and Coronary Artery Disease in Young Male Anabolic Androgenic Steroid Users
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.
- Conditions
- Coronary Artery Disease
- Being tested
- Coronary Computed Tomography Angiography, Macrophage cholesterol efflux mediated by HDL
- Keywords
- Coronary artery disease; HDL; anabolic steroids
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Computed Tomography AngiographyDiagnostic test
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 HDLDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Diagnostic Test: Coronary Computed Tomography Angiography; Diagnostic Test: Macrophage cholesterol efflux mediated by HDL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start1 Apr 2015
- Primary completion1 Apr 2016
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Maria Janieire de Nazaré Nunes Alves, University of Sao Paulo General Hospital
- Investigators
- Maria Janieire NN Alves, MD, Principal investigator, Heart Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03450837
- Sponsor's protocol ID
- CAD-AnabolicAndrogenicSteroids
- Status last verified
- Feb 2018
- First submitted
- 15 Feb 2018
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- 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 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diminished Macrophage Cholesterol Efflux Mediated by HDL and Coronary Artery Disease in Young Male Anabolic Androgenic Steroid Users
- ClinicalTrials.gov ID
- NCT03450837
- Acronym / sponsor ID
- CAD-AnabolicAndrogenicSteroids
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary artery disease; HDL; anabolic steroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 1 Apr 2016 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 1 Mar 2018 (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.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anabolic androgenic steroids users | – | Diagnostic Test: Coronary Computed Tomography Angiography, Diagnostic Test: Macrophage cholesterol efflux mediated by HDLThis 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 |
| Anabolic androgenic steroids nonusers | – | Diagnostic Test: Coronary Computed Tomography Angiography, Diagnostic Test: Macrophage cholesterol efflux mediated by HDLThis 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 |
| Sedentary control | – | Diagnostic Test: Coronary Computed Tomography Angiography, Diagnostic Test: Macrophage cholesterol efflux mediated by HDLThis group were sedentary men without cardiovascular disease. Coronary Computed Tomography Angiography and Macrophage cholesterol efflux mediated by HDL |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Smoking;
- Alcohol consumption;
- Use of diuretics and/or antihypertensive medications;
- Liver and kidney disease
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 |
|---|---|---|
| Coronary Computed Tomography AngiographyTo 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 test | Anabolic androgenic steroids nonusers, Anabolic androgenic steroids users, Sedentary control |
| Macrophage cholesterol efflux mediated by HDLMacrophages 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 | Diagnostic test | Anabolic androgenic steroids nonusers, Anabolic androgenic steroids users, Sedentary control |
Primary outcome
Concentration and the functionality of HDL
Time frame: 1 day
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 secondary outcome
Prevalence of CAD in young men anabolic steroids users
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2018.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Maria Janieire NN Alves, MD principal investigator
Heart Institute
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by University of Sao Paulo General Hospital.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration and the functionality of HDL (time frame: 1 day). 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 1 Mar 2018.