Clinical trial NCT01174485: Effects of Liposuction and Exercise Training on Metabolism, Lipid Profile and Adiposity in Women
Official title: Effects of Liposuction and Exercise Training on Metabolism, Lipid Profile and Adiposity in Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy Subjects
Keywords: Liposuction
exercise
metabolism
adiposity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-08-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Body composition
timeFrame: 2 months post-intervention
measure: Body composition
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Insulin Sensitivity
timeFrame: 2 months post-intervention
measure: Total cholesterol, LDL-c, HDL-c, VLDL-c and triacylglycerol plasma levels
timeFrame: 2 months post-intervention
measure: Cytokine plasma levels - IL-6, TNF-alpha, IL-10, leptin and adiponectin levels
timeFrame: 2 months post-intervention
measure: Insulin Sensitivity
timeFrame: 6 months post-intervention
measure: Total cholesterol, LDL-c, HDL-c, VLDL-c and triacylglycerol plasma levels
timeFrame: 6 months post-intervention
measure: Cytokine plasma levels - IL-6, TNF-alpha, IL-10, leptin and adiponectin levels
timeFrame: 6 months post-intervention
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Escola de Educação Física e Esporte da Universidade de São Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Antonio H Lancha Jr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.