NCT04294238

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

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

January 30, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

February 25, 2020

Last Update Submit

March 2, 2020

Conditions

Keywords

Obesity, Aerobic exercise, HDL subclass, Proteome, function

Outcome Measures

Primary Outcomes (2)

  • The percentage change of HDL cholesterol efflux capacity

    The primary outcome was the mearsurement of HDL function for removing excess cholesterol from peripheral cells

    12 week

  • Proteome alteration of HDL subclass

    HDL proteome was analyzed by mass spectrometry using label-free protein quantification.

    12 week

Study Arms (1)

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.

Behavioral: Aerobic exercise

Interventions

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.

Post-exercise

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Participants with cardiovascular disease, diabetes or other chronic diseases, treatment with any medications, and had surgical procedures within the last 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jingfeng Wang

    Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Self-control study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 25, 2020

First Posted

March 4, 2020

Study Start

January 30, 2018

Primary Completion

January 20, 2020

Study Completion

February 20, 2020

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL
Time Frame
The data will become available at 01/01/2021 and for 1 year.

Locations