Healthy SubjectsEarly Phase 1NCT01174485
Effects of Liposuction and Exercise Training on Metabolism, Lipid Profile and Adiposity in Women
A Early Phase 1 study testing exercise in people with Healthy Subjects, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 20 to 36 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2010to Apr 2011
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 36 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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;
Who cannot join
- Health problems that impede surgery or exercise training;
- Be in chronic use of antibiotics or antiinflammatory medication.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Escola de Educação Física e Esporte da Universidade de São Paulo
São Paulo, São Paulo, 05508-900
About this study
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.
- Conditions
- Healthy Subjects
- Being tested
- exercise
- Keywords
- Liposuction, exercise, metabolism, adiposity
- Medical subject headings
- Motor Activity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseProcedure or surgery
combined resistance and aerobic training
| Study group | Role | What they receive |
|---|---|---|
| exercise | Experimental | exercise plus liposuction Receives: Procedure: exercise |
| sedentary | No intervention | physical inactivity plus liposuction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months post-intervention
Secondary outcomes (6)
Insulin Sensitivity
Insulin sensitivity will be assessed by an oral glucose tolerance test
Measured: 2 months post-intervention
Total cholesterol, LDL-c, HDL-c, VLDL-c and triacylglycerol plasma levels
Measured: 2 months post-intervention
Cytokine plasma levels - IL-6, TNF-alpha, IL-10, leptin and adiponectin levels
Measured: 2 months post-intervention
Insulin Sensitivity
Insulin sensitivity will be assessed by an oral glucose tolerance test
Measured: 6 months post-intervention
Total cholesterol, LDL-c, HDL-c, VLDL-c and triacylglycerol plasma levels
Measured: 6 months post-intervention
Cytokine plasma levels - IL-6, TNF-alpha, IL-10, leptin and adiponectin levels
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Antonio H Lancha Jr, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174485
- Sponsor's protocol ID
- EEFEUSP-LIPO
- Status last verified
- Apr 2011
- First submitted
- 25 Jun 2010
- Last updated
- 13 May 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22539589
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Liposuction and Exercise Training on Metabolism, Lipid Profile and Adiposity in Women
- ClinicalTrials.gov ID
- NCT01174485
- Acronym / sponsor ID
- EEFEUSP-LIPO
- Conditions
- Healthy Subjects
- Keywords
- Liposuction, exercise, metabolism, adiposity
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 3 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise | Experimental | Procedure: exerciseexercise plus liposuction |
| sedentary | No intervention | –physical inactivity plus liposuction |
Who may qualify
- Ages
- 20 to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (2 listed)
- Health problems that impede surgery or exercise training;
- Be in chronic use of antibiotics or antiinflammatory medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercisecombined resistance and aerobic training | Procedure or surgery | exercise |
Primary outcome
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.
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 secondary outcomes
Insulin Sensitivity
Time frame: 2 months post-intervention
Total cholesterol, LDL-c, HDL-c, VLDL-c and triacylglycerol plasma levels
Time frame: 2 months post-intervention
Cytokine plasma levels - IL-6, TNF-alpha, IL-10, leptin and adiponectin levels
Time frame: 2 months post-intervention
Insulin Sensitivity
Time frame: 6 months post-intervention
Total cholesterol, LDL-c, HDL-c, VLDL-c and triacylglycerol plasma levels
Time frame: 6 months post-intervention
Cytokine plasma levels - IL-6, TNF-alpha, IL-10, leptin and adiponectin levels
Time frame: 6 months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2011.
- Derived from this study: PubMed 22539589Benatti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio H Lancha Jr, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing exercise in people with Healthy Subjects, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: 2 months post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01174485, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2011.