Effects of Liposuction and Exercise Training on Metabolism, Lipid Profile and Adiposity in Women

Healthy Subjects Clinical Trial

Official title:

Effects of Liposuction and Exercise Training on Metabolism, Lipid Profile and Adiposity in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01174485
• Other study ID #: EEFEUSP-LIPO
• Status: Completed
• Phase: Phase 0
• First received: June 25, 2010
• Last updated: May 11, 2011
• Start date: August 2010
• Est. completion date: April 2011

Study information

• Verified date: April 2011
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 36 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Procedure:
• exercise
combined resistance and aerobic training

Locations

Country	Name	City	State
Brazil	Escola de Educação Física e Esporte da Universidade de São Paulo	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Insulin Sensitivity	Insulin sensitivity will be assessed by an oral glucose tolerance test	2 months post-intervention	No
Secondary	Total cholesterol, LDL-c, HDL-c, VLDL-c and triacylglycerol plasma levels		2 months post-intervention	No
Secondary	Cytokine plasma levels - IL-6, TNF-alpha, IL-10, leptin and adiponectin levels		2 months post-intervention	No
Secondary	Insulin Sensitivity	Insulin sensitivity will be assessed by an oral glucose tolerance test	6 months post-intervention	No
Secondary	Total cholesterol, LDL-c, HDL-c, VLDL-c and triacylglycerol plasma levels		6 months post-intervention	No
Secondary	Cytokine plasma levels - IL-6, TNF-alpha, IL-10, leptin and adiponectin levels		6 months post-intervention	No