Effects of Liposuction and Exercise Training on Metabolism, Lipid Profile and Adiposity in Women
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Aug 2010
Shorter than P25 for early_phase_1
1 active site
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
First Submitted
Initial submission to the registry
June 25, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedFirst Posted
Study publicly available on registry
August 3, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMay 13, 2011
April 1, 2011
8 months
June 25, 2010
May 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Body composition
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
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 Outcomes (6)
Insulin Sensitivity
2 months post-intervention
Total cholesterol, LDL-c, HDL-c, VLDL-c and triacylglycerol plasma levels
2 months post-intervention
Cytokine plasma levels - IL-6, TNF-alpha, IL-10, leptin and adiponectin levels
2 months post-intervention
Insulin Sensitivity
6 months post-intervention
Total cholesterol, LDL-c, HDL-c, VLDL-c and triacylglycerol plasma levels
6 months post-intervention
- +1 more secondary outcomes
Study Arms (2)
exercise
EXPERIMENTALexercise plus liposuction
sedentary
NO INTERVENTIONphysical inactivity plus liposuction
Interventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- Health problems that impede surgery or exercise training;
- Be in chronic use of antibiotics or antiinflammatory medication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Escola de Educação Física e Esporte da Universidade de São Paulo
São Paulo, São Paulo, 05508-900, Brazil
Related Publications (1)
Benatti F, Solis M, Artioli G, Montag E, Painelli V, Saito F, Baptista L, Costa LA, Neves R, Seelaender M, Ferriolli E, Pfrimer K, Lima F, Roschel H, Gualano B, Lancha A Jr. Liposuction induces a compensatory increase of visceral fat which is effectively counteracted by physical activity: a randomized trial. J Clin Endocrinol Metab. 2012 Jul;97(7):2388-95. doi: 10.1210/jc.2012-1012. Epub 2012 Apr 26.
PMID: 22539589DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio H Lancha Jr, PhD
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 25, 2010
First Posted
August 3, 2010
Study Start
August 1, 2010
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
May 13, 2011
Record last verified: 2011-04