ObesityNCT04294238
The Function and Proteome Alteration of HDL Subclass After Aerobic Exercise
A study testing Aerobic exercise in people with Obesity, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Obesity is one of the most important risk factors for cardiovascular disease (CVD). HDL protein composition can be altered without a change in cholesterol content. Alteration of the HDL proteome can result in dysfunctional HDL particles with reduced ability to protect against CVD. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men only
- Conditions the study is for
- Obesity
- What is being tested?
- Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2018to 20 Feb 2020
- Phase
- Interventional
- 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 30 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Inactive youth males with abdominal obesity: BMI>28 (weight in kilograms divided by height in meters squared) and weight stable for 6 months, waist to height ratio was ≥0.5 and/or waist circumference was ≥102 centimetres between the ages of 18 and 30 years.
Who cannot join
- Participants with cardiovascular disease, diabetes or other chronic diseases, treatment with any medications, and had surgical procedures within the last 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong
About this study
Official title: Effects of Moderate Aerobic Exercise on the Proteome and Function Alteration of HDL Sub-Fractions in Male Youth With Abdominal Obesity
Obesity is one of the most important risk factors for cardiovascular disease (CVD). HDL protein composition can be altered without a change in cholesterol content. Alteration of the HDL proteome can result in dysfunctional HDL particles with reduced ability to protect against CVD. The aim of this study was to evaluate the influence of moderate aerobic exercise on HDL protein composition and its related function. This was a self-control study including 6 inactive male youths with abdominal obesity. HDL functions and its associations with proteome alteration would be analysized.
Read the detailed description
The aim of present study is to test the effects of 12-week moderate aerobic exercise on the proteome and function alteration of HDL sub-fractions in male youth with abdominal obesity.
Study participants: youth males with abdominal obesity between the ages of 18 and 30 years were eligible for participation. Exclusion criteria were cardiovascular disease, diabetes or other chronic diseases, treatment with any medications, and had surgical procedures within the last 6 months. This study was approved by the Medical Ethics Committee at the Sun Yat-sen Memorial Hospital, complies with the Declaration of Helsinki principles and written informed consent would be obtained from all participants.
Data collection: anthropometric measurements, physical examination and blood samples were collected at 0 and 12 weeks. Cardiorespiratory measurements of each participant was measured using a bicycle-based graded exercise test at baseline.
Intervention: the exercise intervention consisted of 12 weeks of aerobic exercise training of moderate intensity (about 75 percentage of peak heart rate) of 40-60 min per time, 3-5 times per week, at least 150 min per week. All participants were instructed to maintain their usual dietary intakes. Completing a minimum of 80 percentage training sessions was satisfactory.
HDL isolation: HDL particles were fractionated into small, medium and large (S/M/L)-HDL subfractions by an ÄKTA fast protein liquid chromatography (FPLC) system.
Proteomics Experiments: equal volumes of L/M/S-HDL subclass were applied to the CSH resin, trypsinized, and then recognized via LC-MS. HDL proteins in HDL subclass were detected by MS-based label-free quantitation
HDL functions: cholesterol efflux capacity, anti-inflammation and anti-oxidative capacity, endothelial protective function
Analysis: data are expressed as mean and SD for continuous variables, or percentage for category variables. Difference of variables between baseline and after exercise were compared using analysis of Paired t-test or Mann Whitney U test. P<0.05 was considered statistically significant.
- Conditions
- Obesity
- Being tested
- Aerobic exercise
- Keywords
- Obesity, Aerobic exercise, HDL subclass, Proteome, function
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseBehavioural
The aerobic exercise intervention consisted of 12 weeks of aerobic exercise training of moderate intensity (about 75 percentage peak heart rate) of 40-60 min per time, 3-5 times per week, at least 150 min per week.
| Study group | Role | What they receive |
|---|---|---|
| Post-exercise | Experimental | The aerobic exercise intervention consisted of 12 weeks of aerobic exercise training of moderate intensity (about 75 percentage of peak heart rate) of 40-60 min per time, 3-5 times per week, at least 150 min per week. Receives: Behavioral: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage change of HDL cholesterol efflux capacity
The primary outcome was the mearsurement of HDL function for removing excess cholesterol from peripheral cells
Measured: 12 week
Proteome alteration of HDL subclass
HDL proteome was analyzed by mass spectrometry using label-free protein quantification.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start30 Jan 2018
- Primary completion20 Jan 2020
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Self-control study
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingfeng Wang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Jingfeng Wang, Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294238
- Sponsor's protocol ID
- SYSEC-KY-KS-2019-011
- Status last verified
- Mar 2020
- First submitted
- 25 Feb 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Due to restrictions that protect participant privacy, data are available upon request. The data ( study protocol) will be available upon request to all interested researchers.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Moderate Aerobic Exercise on the Proteome and Function Alteration of HDL Sub-Fractions in Male Youth With Abdominal Obesity
- ClinicalTrials.gov ID
- NCT04294238
- Acronym / sponsor ID
- SYSEC-KY-KS-2019-011
- Conditions
- Obesity
- Keywords
- Obesity, Aerobic exercise, HDL subclass, Proteome, function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 4 Mar 2020 (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.
Obesity is one of the most important risk factors for cardiovascular disease (CVD). HDL protein composition can be altered without a change in cholesterol content. Alteration of the HDL proteome can result in dysfunctional HDL particles with reduced ability to protect against CVD. The aim of this study was to evaluate the influence of moderate aerobic exercise on HDL protein composition and its related function. This was a self-control study including 6 inactive male youths with abdominal obesity. HDL functions and its associations with proteome alteration would be analysized.
Detailed description
The aim of present study is to test the effects of 12-week moderate aerobic exercise on the proteome and function alteration of HDL sub-fractions in male youth with abdominal obesity.
Study participants: youth males with abdominal obesity between the ages of 18 and 30 years were eligible for participation. Exclusion criteria were cardiovascular disease, diabetes or other chronic diseases, treatment with any medications, and had surgical procedures within the last 6 months. This study was approved by the Medical Ethics Committee at the Sun Yat-sen Memorial Hospital, complies with the Declaration of Helsinki principles and written informed consent would be obtained from all participants.
Data collection: anthropometric measurements, physical examination and blood samples were collected at 0 and 12 weeks. Cardiorespiratory measurements of each participant was measured using a bicycle-based graded exercise test at baseline.
Intervention: the exercise intervention consisted of 12 weeks of aerobic exercise training of moderate intensity (about 75 percentage of peak heart rate) of 40-60 min per time, 3-5 times per week, at least 150 min per week. All participants were instructed to maintain their usual dietary intakes. Completing a minimum of 80 percentage training sessions was satisfactory.
HDL isolation: HDL particles were fractionated into small, medium and large (S/M/L)-HDL subfractions by an ÄKTA fast protein liquid chromatography (FPLC) system.
Proteomics Experiments: equal volumes of L/M/S-HDL subclass were applied to the CSH resin, trypsinized, and then recognized via LC-MS. HDL proteins in HDL subclass were detected by MS-based label-free quantitation
HDL functions: cholesterol efflux capacity, anti-inflammation and anti-oxidative capacity, endothelial protective function
Analysis: data are expressed as mean and SD for continuous variables, or percentage for category variables. Difference of variables between baseline and after exercise were compared using analysis of Paired t-test or Mann Whitney U test. P<0.05 was considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Self-control study
| Arm | Type | Receives |
|---|---|---|
| Post-exercise | Experimental | Behavioral: Aerobic exerciseThe aerobic exercise intervention consisted of 12 weeks of aerobic exercise training of moderate intensity (about 75 percentage of peak heart rate) of 40-60 min per time, 3-5 times per week, at least 150 min per week. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Inactive youth males with abdominal obesity: BMI>28 (weight in kilograms divided by height in meters squared) and weight stable for 6 months, waist to height ratio was ≥0.5 and/or waist circumference was ≥102 centimetres between the ages of 18 and 30 years.
Key exclusion criteria (1 listed)
- Participants with cardiovascular disease, diabetes or other chronic diseases, treatment with any medications, and had surgical procedures within the last 6 months.
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 |
|---|---|---|
| Aerobic exerciseThe aerobic exercise intervention consisted of 12 weeks of aerobic exercise training of moderate intensity (about 75 percentage peak heart rate) of 40-60 min per time, 3-5 times per week, at least 150 min per week. | Behavioural | Post-exercise |
Primary outcome
The percentage change of HDL cholesterol efflux capacity
Time frame: 12 week
The primary outcome was the mearsurement of HDL function for removing excess cholesterol from peripheral cells
Proteome alteration of HDL subclass
Time frame: 12 week
HDL proteome was analyzed by mass spectrometry using label-free protein quantification.
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 4 Mar 2020.
- Individual participant dataSharing planned: Yes. Due to restrictions that protect participant privacy, data are available upon request. The data ( study protocol) will be available upon request to all interested researchers.
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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.
Jingfeng Wang principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Obesity, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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 1 inclusion and 1 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 4 Mar 2020. 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 China. 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?
The percentage change of HDL cholesterol efflux capacity (time frame: 12 week). The study lists 2 primary outcomes in all. 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 4 Mar 2020.