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

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01174485
First received: June 25, 2010
Last updated: May 11, 2011
Last verified: April 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy Subjects
 Procedure: exercise
 Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Effects of Liposuction and Exercise Training on Metabolism, Lipid Profile and Adiposity in Women

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Body composition [ Time Frame: 2 months post-intervention ] [ Designated as safety issue: No ]
    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.

  • Body composition [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Insulin Sensitivity [ Time Frame: 2 months post-intervention ] [ Designated as safety issue: No ]
    Insulin sensitivity will be assessed by an oral glucose tolerance test

  • Total cholesterol, LDL-c, HDL-c, VLDL-c and triacylglycerol plasma levels [ Time Frame: 2 months post-intervention ] [ Designated as safety issue: No ]
  • Cytokine plasma levels - IL-6, TNF-alpha, IL-10, leptin and adiponectin levels [ Time Frame: 2 months post-intervention ] [ Designated as safety issue: No ]
  • Insulin Sensitivity [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
    Insulin sensitivity will be assessed by an oral glucose tolerance test

  • Total cholesterol, LDL-c, HDL-c, VLDL-c and triacylglycerol plasma levels [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]
  • Cytokine plasma levels - IL-6, TNF-alpha, IL-10, leptin and adiponectin levels [ Time Frame: 6 months post-intervention ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: exercise
exercise plus liposuction
 Procedure: exercise
combined resistance and aerobic training
No Intervention: sedentary
physical inactivity plus liposuction

  Eligibility

Ages Eligible for Study:   20 Years to 36 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01174485

Locations
Brazil
Escola de Educação Física e Esporte da Universidade de São Paulo
São Paulo, SP, Brazil, 05508-900
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Antonio H Lancha Jr, PhD University of Sao Paulo
  More Information

No publications provided by University of Sao Paulo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Fabiana Braga Benatti, Escola de Educação Física e Esporte da Universidade de São Paulo
ClinicalTrials.gov Identifier: NCT01174485     History of Changes
Other Study ID Numbers: EEFEUSP-LIPO
Study First Received: June 25, 2010
Last Updated: May 11, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Liposuction
exercise
metabolism
adiposity
Exercise

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013