Low HDL CholesterolNCT02106013
Association Between HDL Functions and Atherosclerotic Burden in Healthy Individuals
An observational study of Low HDL Cholesterol, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
This is a study of HDL function in healthy individuals classified in three groups according to their HDL-cholesterol levels (Low HDL-C, Intermediate HDl-C and High HDL-C), with the purpose of investigating which characteristics of the HDL particle might be associated to atherosclerotic burden, characterized by carotid… Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Low HDL Cholesterol
- How many people
- 101 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2008to Mar 2014
- 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals who sought governmental primary care centers of the city of Campinas, SP, Brazil.
Who may be able to join
- glucose <100 mg/dL
- Urea <71 mg/dL
- Creatinine < 1.20 mg/dL
- Uric acid <7.0 mg/dL
- Alanine aminotransferase <50 U/L
- Aspartate aminotransferase < 33 U/L
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- Gamma-glutamyl transferase <71 U/L
- Alkaline phosphatase <129 U/L
- Thyroid stimulating hormone between 0.41 and 4.50 μUI/mL
- Free thyroxin between 0.9 and 1.8 ng/dL
Who cannot join
- Symptomatic cardiovascular disease
- LDL-cholesterol ≥130 mg/dL
- Triglycerides ≥150 mg/dL
- Metabolic syndrome
- BMI ≥ 30 kg/m2
- Smoking habit
- Daily intake of alcohol >14g
- Regular use of medical treatments
Trial locations and contacts
1 site in 1 country.
About this study
This is a study of HDL function in healthy individuals classified in three groups according to their HDL-cholesterol levels (Low HDL-C, Intermediate HDl-C and High HDL-C), with the purpose of investigating which characteristics of the HDL particle might be associated to atherosclerotic burden, characterized by carotid intima-media thickness above 1mm.
Read the detailed description
Selection: Study participants are initially selected trough the evaluation of consecutive lipid profiles from individuals who spontaneously seek governmental primary care centers of the city of Campinas, Sao Paulo, Brazil. Telephone-based screening interviews are performed, followed by in-person clinical evaluation and blood exams.
Biochemical analyses: Glucose, triglycerides, HDL-C and c-reactive protein (CRP) are measured in an automated Modular® Analytics Evo (Roche Diagnostics, Burgess Hill, West Sussex, UK), using Roche Diagnostics® reagents (Mannheim, Germany). LDL-cholesterol is calculated by the Friedewald formula. Serum insulin levels are measured using ELISA (Millipore, Massachusetts, USA). The Homeostasis Model Assessment (HOMA) Calculator version 2.2 (University of Oxford, UK) is used to estimate insulin sensitivity. Apolipoproteins A-I and B-100 and lipoprotein (a) are determined by nephelometry in an automated system and reagents from Dade-Behring® (Marburg, Germany).
Carotid artery ultrasound: Carotid artery atherosclerosis is estimated by using high-resolution B-mode ultrasound, at the posterior wall of the common carotid artery.
Lipoprotein isolation: HDL from each study participant is isolated from plasma, through ultracentrifugation (Beckman Coulter Inc., Palo Alto, USA).
HDL chemical composition: Using commercially available enzymatic kits, HDL content of total proteins, total cholesterol, free cholesterol, phospholipids, triglycerides and apolipoprotein A-I are measured. Cholesteryl ester (CE) is calculated as the difference between total cholesterol and free cholesterol times 1.67. HDL molar concentration is estimated based on particle total mass and molecular weight.
HDL physical-chemical characterization: HDL particle size is determined using dynamic light scattering, and zeta potential using laser Doppler micro-electrophoresis.
Determination of proteins involved in HDL metabolism: Cholesteryl ester transfer protein, phospholipids transfer protein, lipoprotein lipase, hepatic lipase and lecithin:cholesterol acyl transferase activities are determined trough radiometric exogenous assays.
HDL functions: Cholesterol efflux capacity, antioxidant activity, susceptibility to oxidation, anti-inflammatory activity and platelet aggregation inhibition are measured using straightforward and consolidated methodologies.
Statistical Analyses: Differences between groups are evaluated using ANOVA or Kruskal-Wallis, with Bonferroni's post-hoc multiple comparison analysis, according to variable distribution. Chi-Square is used to compare categorical data. Analysis of covariance (ANCOVA) adjusted for confounding variables is also used, after checking variables with histograms, normality plots, and residual scatter plots that tested for linearity, normality, and variance. Pearson's correlation test is used to assess the relationships between variables. A two-sided p-value of 0.05 is considered significant.
- Conditions
- Low HDL Cholesterol
- Keywords
- HDL, Carotid artery intima-media thickness, Cholesterol efflux capacity, Antioxidant effect of HDL, Susceptibility to oxidation of HDL, Anti-inflammatory effect of HDL, Platelet aggregation inhibition by HDL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low HDL-C | Study participants with HDL-C levels below the 10th percentile (HDL-C ≤32 mg/dL) | |
| Intermediate HDL-C | Study participants with HDL-C levels between 40th and 60th percentiles (40≤HDL-C≤67 mg/dL) | |
| High HDL-C | Study participants with HDL-C levels above the 90th percentile (HDL-C ≥78mg/dL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol efflux capacity of HDL
This is a cross-sectional study and as such the cholesterol efflux capacity will be measured using the plasma sample collected at admission into the study
Measured: The analysis will be performed using plasma obtained at admission into the study
Secondary outcomes (4)
Antioxidant activity of HDL
This is a cross-sectional study and as such the cholesterol efflux capacity will be measured using the plasma sample collected at admission into the study
Measured: The analysis will be performed using plasma obtained at admission into the study
Susceptibility to oxidation of HDL
This is a cross-sectional study and as such the cholesterol efflux capacity will be measured using the plasma sample collected at admission into the study
Measured: The analysis will be performed using plasma obtained at admission into the study
Anti-inflammatory activity of HDL
This is a cross-sectional study and as such the cholesterol efflux capacity will be measured using the plasma sample collected at admission into the study
Measured: The analysis will be performed using plasma obtained at admission into the study
Platelet aggregation inhibition by HDL
This is a cross-sectional study and as such the cholesterol efflux capacity will be measured using the plasma sample collected at admission into the study
Measured: The analysis will be performed using plasma obtained at admission into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startApr 2008
- Primary completionNov 2013
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low HDL CholesterolStudies of the same condition, open and under way.
- 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
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Responsible party
- Principal investigator, Andrei Carvalho Sposito, University of Campinas, Brazil
- Investigators
- Andrei C Sposito, PhD MD, Principal investigator, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02106013
- Sponsor's protocol ID
- BHS2
- Status last verified
- Apr 2014
- First submitted
- 30 Mar 2014
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between HDL Functions and Atherosclerotic Burden in Healthy Individuals
- ClinicalTrials.gov ID
- NCT02106013
- Acronym / sponsor ID
- BHS2
- Conditions
- Low HDL Cholesterol
- Keywords
- HDL, Carotid artery intima-media thickness, Cholesterol efflux capacity, Antioxidant effect of HDL, Susceptibility to oxidation of HDL, Anti-inflammatory effect of HDL, Platelet aggregation inhibition by HDL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico
- Study start
- Apr 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 7 Apr 2014 (estimated)
- 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.
This is a study of HDL function in healthy individuals classified in three groups according to their HDL-cholesterol levels (Low HDL-C, Intermediate HDl-C and High HDL-C), with the purpose of investigating which characteristics of the HDL particle might be associated to atherosclerotic burden, characterized by carotid intima-media thickness above 1mm.
Detailed description
Selection: Study participants are initially selected trough the evaluation of consecutive lipid profiles from individuals who spontaneously seek governmental primary care centers of the city of Campinas, Sao Paulo, Brazil. Telephone-based screening interviews are performed, followed by in-person clinical evaluation and blood exams.
Biochemical analyses: Glucose, triglycerides, HDL-C and c-reactive protein (CRP) are measured in an automated Modular® Analytics Evo (Roche Diagnostics, Burgess Hill, West Sussex, UK), using Roche Diagnostics® reagents (Mannheim, Germany). LDL-cholesterol is calculated by the Friedewald formula. Serum insulin levels are measured using ELISA (Millipore, Massachusetts, USA). The Homeostasis Model Assessment (HOMA) Calculator version 2.2 (University of Oxford, UK) is used to estimate insulin sensitivity. Apolipoproteins A-I and B-100 and lipoprotein (a) are determined by nephelometry in an automated system and reagents from Dade-Behring® (Marburg, Germany).
Carotid artery ultrasound: Carotid artery atherosclerosis is estimated by using high-resolution B-mode ultrasound, at the posterior wall of the common carotid artery.
Lipoprotein isolation: HDL from each study participant is isolated from plasma, through ultracentrifugation (Beckman Coulter Inc., Palo Alto, USA).
HDL chemical composition: Using commercially available enzymatic kits, HDL content of total proteins, total cholesterol, free cholesterol, phospholipids, triglycerides and apolipoprotein A-I are measured. Cholesteryl ester (CE) is calculated as the difference between total cholesterol and free cholesterol times 1.67. HDL molar concentration is estimated based on particle total mass and molecular weight.
HDL physical-chemical characterization: HDL particle size is determined using dynamic light scattering, and zeta potential using laser Doppler micro-electrophoresis.
Determination of proteins involved in HDL metabolism: Cholesteryl ester transfer protein, phospholipids transfer protein, lipoprotein lipase, hepatic lipase and lecithin:cholesterol acyl transferase activities are determined trough radiometric exogenous assays.
HDL functions: Cholesterol efflux capacity, antioxidant activity, susceptibility to oxidation, anti-inflammatory activity and platelet aggregation inhibition are measured using straightforward and consolidated methodologies.
Statistical Analyses: Differences between groups are evaluated using ANOVA or Kruskal-Wallis, with Bonferroni's post-hoc multiple comparison analysis, according to variable distribution. Chi-Square is used to compare categorical data. Analysis of covariance (ANCOVA) adjusted for confounding variables is also used, after checking variables with histograms, normality plots, and residual scatter plots that tested for linearity, normality, and variance. Pearson's correlation test is used to assess the relationships between variables. A two-sided p-value of 0.05 is considered significant.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low HDL-C | – | –Study participants with HDL-C levels below the 10th percentile (HDL-C ≤32 mg/dL) |
| Intermediate HDL-C | – | –Study participants with HDL-C levels between 40th and 60th percentiles (40≤HDL-C≤67 mg/dL) |
| High HDL-C | – | –Study participants with HDL-C levels above the 90th percentile (HDL-C ≥78mg/dL) |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals who sought governmental primary care centers of the city of Campinas, SP, Brazil.
Key inclusion criteria (10 listed)
- glucose <100 mg/dL
- Urea <71 mg/dL
- Creatinine < 1.20 mg/dL
- Uric acid <7.0 mg/dL
- Alanine aminotransferase <50 U/L
Key exclusion criteria (8 listed)
- Symptomatic cardiovascular disease
- LDL-cholesterol ≥130 mg/dL
- Triglycerides ≥150 mg/dL
- Metabolic syndrome
- BMI ≥ 30 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cholesterol efflux capacity of HDL
Time frame: The analysis will be performed using plasma obtained at admission into the study
This is a cross-sectional study and as such the cholesterol efflux capacity will be measured using the plasma sample collected at admission into the study
4 secondary outcomes
Antioxidant activity of HDL
Time frame: The analysis will be performed using plasma obtained at admission into the study
Susceptibility to oxidation of HDL
Time frame: The analysis will be performed using plasma obtained at admission into the study
Anti-inflammatory activity of HDL
Time frame: The analysis will be performed using plasma obtained at admission into the study
Platelet aggregation inhibition by HDL
Time frame: The analysis will be performed using plasma obtained at admission into the study
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 7 Apr 2014.
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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.
Andrei C Sposito, PhD MD principal investigator
University of Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low HDL Cholesterol, run by University of Campinas, Brazil at 1 site in Brazil.
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 10 inclusion and 8 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 7 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Cholesterol efflux capacity of HDL (time frame: The analysis will be performed using plasma obtained at admission into the study). 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 7 Apr 2014.