Obesity, AbdominalNCT02110927
Microcurrent and Aerobic Exercise Effects in Abdominal Fat
A study testing Transcutaneous microcurrent and Aerobic exercise in people with Obesity, Abdominal, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
Trial summary
The purpose of this study was to analyze microcurrent short term effects used with aerobic exercise on abdominal fat. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal
- What is being tested?
- Transcutaneous microcurrent and Aerobic exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePortugal
- Study dates
- Feb 2014to Oct 2014
- Phase
- Interventional
- 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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 30 years.
Who cannot join
- submitted to other fat reduce procedure, to show cardiovascular risk factors or diseases and/or any physical condition limiting aerobic exercise. To present any contraindications to microcurrent and/or aerobic exercise, to take medication that influence lipid metabolism, and to be pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microcurrent and Aerobic Exercise Effects in Glycerol, Catecholamines, Energetic Source and Muscle Activity
The purpose of this study was to analyze microcurrent short term effects used with aerobic exercise on abdominal fat.
Read the detailed description
Nutritional patterns have been changed during twenty-first century with sugar and fat's high proportions that allied to sedentary lifestyle increased body fat. There is already a well establish relationship between total body fat excess, cardiometabolic diseases and increased mortality, knowing that abdominal fat (android pattern), different from body index, presents an additional influence to health risks. Women with their abdominal adipocytes (visceral fat) show an increased lipolytic activity that releases free fat acids to the systemic and portal circulation leading to a metabolic syndrome, increasing the risk of cardiovascular diseases.
Aerobic exercise is a way to decrease fat as it stimulates lipolysis through an increase in catecholamine's level resulting from a sympathetic system nervous activity raise. The most used exercise for lipid elimination is the prolonged aerobic moderate exercise with a minimum of 30 minutes.
Nevertheless aerobic exercise practice reduce globally lipidic sources and not locally .
Electrolipolysis using microcurrent has been used in clinical practice as a technique to reduce abdominal fat. This technique can be applied transcutaneously or percutaneously seeming that the former is not so effective as skin can be an obstacle to the current effect on visceral and subcutaneous fat .
Abdominal fat excess is associated with cardiometabolic diseases and can be prevented using microcurrent and aerobic exercise to stimulate lipolysis.
- Conditions
- Obesity, Abdominal
- Being tested
- Transcutaneous microcurrent, Aerobic exercise
- Keywords
- Abdominal fat, Metabolic syndrome, Microcurrent, Aerobic exercise, Lipolysis
- Medical subject headings
- Obesity, Abdominal, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous microcurrentDevice
Microcurrent in the abdominal region with four transcutaneous electrodes in a parallel position, intensity below the sensitivity threshold and a maximum of 1 mA. Every 15 minutes changed from 25 Hz to 10 Hz.
Aerobic exerciseDevice
50 minutes of aerobic moderate-intensity exercise (45-55% of maximal oxygen consumption (VO2 max)) using Karvonen´s formula, performed on a cycloergometer. Were used Borg scale (12-13), Polar® heart monitors to control heart rate and K4b2 to analyze the quantity of oxygen (O2) consumption and carbon dioxide (CO2) produced during exercise.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous microcurrent | Experimental | This group performed aerobic exercise just after microcurrent in the abdominal region with four transcutaneous electrodes in a parallel position, intensity below the sensitivity threshold and a maximum of 1 milliampere (mA). Every 20 minutes changed from 25 hertz (Hz) to 10 Hz Receives: Device: Transcutaneous microcurrent; Device: Aerobic exercise |
| Control group | Placebo comparator | Control group performed aerobic exercise just after microcurrent in the abdominal region with four transcutaneous electrodes in a parallel position, but microcurrent device was switched off. Receives: Device: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in catecholamines and glycerol concentrations
Blood analysis collection was carried out with help from an clinical analysis technician. The volunteers were not fasting.
Measured: 10 minutes before the interventions, after interventions (duration of interventions - 90 minutes) and after 24 hours
Change in proportion of energy source
K4b2 (COSMED ®) was used for analysis of cardiopulmonary gas exchange in real time.
Measured: Immediately before (for 3 minutes) and during exercise (duration of exercise - 50 minutes)
Change in electromyographic activity
Recording the surface electrical activity produced by rectus abdominis and external oblique in front bridge and side bridge exercise, respectively.
Measured: 5 minutes before and after microcurrent
Secondary outcomes (4)
Subcutaneous abdominal fat and visceral abdominal fat
Ultrasound was performed at the end of expiration to measure subcutaneous abdominal fat between xiphoid apophysis and navel, below navel, and above left and right anterior superior iliac spine. Between xiphoid apophysis and navel was also measured visceral abdominal fat. Abdominal fat analyzed by dual-energy x-ray absorptiometry (DEXA).
Measured: 20 minutes before the interventions
Suprailiac, vertical and horizontal abdominal skinfolds
Suprailiac, vertical and horizontal abdominal skinfolds were performed two times in right hemi body, by caliper.
Measured: 20 minutes before the interventions
Perimeters measurements
The perimeters measurements were done, at the end of expiration, at waist level (below last rib), at navel level, at the point immediately above the iliac crests and at trochanters level. The waist-hip ratio was calculated using the waist level perimeter.
divided by trochanters level perimeter.
Measured: 20 minutes before the interventions
Change in cholesterol, triglycerides and glucose concentrations
Blood analysis collection was carried out with help from an clinical analysis technician. The volunteers were not fasting.
Measured: 10 minutes before the interventions, after interventions (duration of interventions - 90 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreia Noites, Escola Superior de Tecnologia da Saúde do Porto
- Investigators
- Andreia Noites, MSc, Principal investigator, Escola Superior de Tecnologia da Saúde do PortoRui Vilarinho, BSc, Study chair, Escola Superior de Tecnologia da Saúde do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110927
- Sponsor's protocol ID
- AN-003
- Status last verified
- Oct 2014
- First submitted
- 21 Mar 2014
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ahmadian M, Wang Y, Sul HS. Lipolysis in adipocytes. Int J Biochem Cell Biol. 2010 May;42(5):555-9. doi: 10.1016/j.biocel.2009.12.009. Epub 2009 Dec 16.
PubMed 20025992Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.
PubMed 17167477Bulow J, Gjeraa K, Enevoldsen LH, Simonsen L. Lipid mobilization from human abdominal, subcutaneous adipose tissue is independent of sex during steady-state exercise. Clin Physiol Funct Imaging. 2006 Jul;26(4):205-11. doi: 10.1111/j.1475-097X.2006.00664.x.
PubMed 16836692
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcurrent and Aerobic Exercise Effects in Glycerol, Catecholamines, Energetic Source and Muscle Activity
- ClinicalTrials.gov ID
- NCT02110927
- Acronym / sponsor ID
- AN-003
- Conditions
- Obesity, Abdominal
- Keywords
- Abdominal fat, Metabolic syndrome, Microcurrent, Aerobic exercise, Lipolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 10 Apr 2014 (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.
The purpose of this study was to analyze microcurrent short term effects used with aerobic exercise on abdominal fat.
Detailed description
Nutritional patterns have been changed during twenty-first century with sugar and fat's high proportions that allied to sedentary lifestyle increased body fat. There is already a well establish relationship between total body fat excess, cardiometabolic diseases and increased mortality, knowing that abdominal fat (android pattern), different from body index, presents an additional influence to health risks. Women with their abdominal adipocytes (visceral fat) show an increased lipolytic activity that releases free fat acids to the systemic and portal circulation leading to a metabolic syndrome, increasing the risk of cardiovascular diseases.
Aerobic exercise is a way to decrease fat as it stimulates lipolysis through an increase in catecholamine's level resulting from a sympathetic system nervous activity raise. The most used exercise for lipid elimination is the prolonged aerobic moderate exercise with a minimum of 30 minutes.
Nevertheless aerobic exercise practice reduce globally lipidic sources and not locally .
Electrolipolysis using microcurrent has been used in clinical practice as a technique to reduce abdominal fat. This technique can be applied transcutaneously or percutaneously seeming that the former is not so effective as skin can be an obstacle to the current effect on visceral and subcutaneous fat .
Abdominal fat excess is associated with cardiometabolic diseases and can be prevented using microcurrent and aerobic exercise to stimulate lipolysis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous microcurrent | Experimental | Device: Transcutaneous microcurrent, Device: Aerobic exerciseThis group performed aerobic exercise just after microcurrent in the abdominal region with four transcutaneous electrodes in a parallel position, intensity below the sensitivity threshold and a maximum of 1 milliampere (mA). Every 20 minutes changed from 25 hertz (Hz) to 10 Hz |
| Control group | Placebo comparator | Device: Aerobic exerciseControl group performed aerobic exercise just after microcurrent in the abdominal region with four transcutaneous electrodes in a parallel position, but microcurrent device was switched off. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age between 18 and 30 years.
Key exclusion criteria (1 listed)
- submitted to other fat reduce procedure, to show cardiovascular risk factors or diseases and/or any physical condition limiting aerobic exercise. To present any contraindications to microcurrent and/or aerobic exercise, to take medication that influence lipid metabolism, and to be pregnant.
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 |
|---|---|---|
| Transcutaneous microcurrentMicrocurrent in the abdominal region with four transcutaneous electrodes in a parallel position, intensity below the sensitivity threshold and a maximum of 1 mA. Every 15 minutes changed from 25 Hz to 10 Hz. | Device | Transcutaneous microcurrent |
| Aerobic exercise50 minutes of aerobic moderate-intensity exercise (45-55% of maximal oxygen consumption (VO2 max)) using Karvonen´s formula, performed on a cycloergometer. Were used Borg scale (12-13), Polar® heart monitors to control heart rate and K4b2 to analyze the quantity of oxygen (O2) consumption and carbon dioxide (CO2) produced during exercise. | Device | Control group, Transcutaneous microcurrent |
Primary outcome
Change in catecholamines and glycerol concentrations
Time frame: 10 minutes before the interventions, after interventions (duration of interventions - 90 minutes) and after 24 hours
Blood analysis collection was carried out with help from an clinical analysis technician. The volunteers were not fasting.
Change in proportion of energy source
Time frame: Immediately before (for 3 minutes) and during exercise (duration of exercise - 50 minutes)
K4b2 (COSMED ®) was used for analysis of cardiopulmonary gas exchange in real time.
Change in electromyographic activity
Time frame: 5 minutes before and after microcurrent
Recording the surface electrical activity produced by rectus abdominis and external oblique in front bridge and side bridge exercise, respectively.
4 secondary outcomes
Subcutaneous abdominal fat and visceral abdominal fat
Time frame: 20 minutes before the interventions
Suprailiac, vertical and horizontal abdominal skinfolds
Time frame: 20 minutes before the interventions
Perimeters measurements
Time frame: 20 minutes before the interventions
Change in cholesterol, triglycerides and glucose concentrations
Time frame: 10 minutes before the interventions, after interventions (duration of interventions - 90 minutes)
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 24 Oct 2014.
- Background: PubMed 20025992Ahmadian M, Wang Y, Sul HS. Lipolysis in adipocytes. Int J Biochem Cell Biol. 2010 May;42(5):555-9. doi: 10.1016/j.biocel.2009.12.009. Epub 2009 Dec 16.
- Background: PubMed 17167477Despres JP, Lemieux I. Abdominal obesity and metabolic syndrome. Nature. 2006 Dec 14;444(7121):881-7. doi: 10.1038/nature05488.
- Background: PubMed 16836692Bulow J, Gjeraa K, Enevoldsen LH, Simonsen L. Lipid mobilization from human abdominal, subcutaneous adipose tissue is independent of sex during steady-state exercise. Clin Physiol Funct Imaging. 2006 Jul;26(4):205-11. doi: 10.1111/j.1475-097X.2006.00664.x.
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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.
Andreia Noites, MSc principal investigator
Escola Superior de Tecnologia da Saúde do Porto
Rui Vilarinho, BSc study chair
Escola Superior de Tecnologia da Saúde do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous microcurrent and Aerobic exercise in people with Obesity, Abdominal, run by Escola Superior de Tecnologia da Saúde do Porto at 1 site in Portugal.
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 1 inclusion and 1 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 24 Oct 2014. 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 Portugal. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change in catecholamines and glycerol concentrations (time frame: 10 minutes before the interventions, after interventions (duration of interventions - 90 minutes) and after 24 hours). The study lists 3 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 NCT02110927, which also lists 3 linked publications.
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 24 Oct 2014.