- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01174485
Effects of Liposuction and Exercise Training on Metabolism, Lipid Profile and Adiposity in Women
May 11, 2011 updated by: University of Sao Paulo
Liposuction is the most popular aesthetic surgery in Brasil and worldwide.
Evidence showing that adipose tissue is a metabolically active tissue led to the suggestion that liposuction could be a viable method for the improvement of metabolic profile through the immediate loss of adipose tissue.
Studies about the effects of liposuction on metabolic profile are conflicting.
A few studies report the improvement of insulin sensitivity, inflammatory markers and lipid profile, others observe no changes and a few report the worsening of metabolic profile.
In addition, animal studies show a compensatory growth of intact adipose tissue in response to lipectomy.
Physical exercise improves insulin sensitivity, lipid profile, inflammatory balance, adipose tissue distribution and increases or preserves free fat mass.
Therefore, liposuction and physical exercise seem to act on similar tissues of the body.
To the investigators knowledge, there are no studies about the associated effects of liposuction and exercise in humans.
However, one can suggest that exercise training associated with liposuction could: [1] attenuate or block the possible fat recovery or compensatory growth; [2] block or reverse the possible harmful effects of liposuction; or [3] exert an additive or synergistic effect to the possible beneficial effects induced by liposuction on metabolic and hormonal profile and inflammatory balance.
Study Overview
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
São Paulo, SP, Brazil, 05508-900
- Escola de Educação Física e Esporte da Universidade de São Paulo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 36 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 20 to 35-year old healthy subjects with a BMI of 22 to 28 Kg/m2;
- Non-smokers;
- Present stable body weight for 6 months (without variations exceeding 4 kg);
- Be in use contraceptive pill for at least 6 months;
Exclusion Criteria:
- Health problems that impede surgery or exercise training;
- Be in chronic use of antibiotics or antiinflammatory medication.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: exercise
exercise plus liposuction
|
combined resistance and aerobic training
|
|
No Intervention: sedentary
physical inactivity plus liposuction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body composition
Time Frame: 2 months post-intervention
|
Body composition will be assessed by hydrostatic weighing in order to measure fat and lean mass and by computer tomography, in order to measure abdominal total, subcutaneous and visceral fat areas and femoral and pelvic subcutaneous fat areas.
|
2 months post-intervention
|
|
Body composition
Time Frame: 6 months post-intervention
|
Body composition will be assessed by hydrostatic weighing in order to measure fat and lean mass and by computer tomography, in order to measure abdominal total, subcutaneous and visceral fat areas and femoral and pelvic subcutaneous fat areas.
|
6 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Insulin Sensitivity
Time Frame: 2 months post-intervention
|
Insulin sensitivity will be assessed by an oral glucose tolerance test
|
2 months post-intervention
|
|
Total cholesterol, LDL-c, HDL-c, VLDL-c and triacylglycerol plasma levels
Time Frame: 2 months post-intervention
|
2 months post-intervention
|
|
|
Cytokine plasma levels - IL-6, TNF-alpha, IL-10, leptin and adiponectin levels
Time Frame: 2 months post-intervention
|
2 months post-intervention
|
|
|
Insulin Sensitivity
Time Frame: 6 months post-intervention
|
Insulin sensitivity will be assessed by an oral glucose tolerance test
|
6 months post-intervention
|
|
Total cholesterol, LDL-c, HDL-c, VLDL-c and triacylglycerol plasma levels
Time Frame: 6 months post-intervention
|
6 months post-intervention
|
|
|
Cytokine plasma levels - IL-6, TNF-alpha, IL-10, leptin and adiponectin levels
Time Frame: 6 months post-intervention
|
6 months post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Antonio H Lancha Jr, PhD, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2010
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
June 25, 2010
First Submitted That Met QC Criteria
August 2, 2010
First Posted (Estimate)
August 3, 2010
Study Record Updates
Last Update Posted (Estimate)
May 13, 2011
Last Update Submitted That Met QC Criteria
May 11, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EEFEUSP-LIPO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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