Metabolic DiseaseNCT03462537
Effect of Aerobic Exercise Associated With Abdominal Laser Therapy
A study testing Low level laser therapy, Aerobic Exercise and Low level laser therapy without power in people with Metabolic Disease, run by Escola Superior de Tecnologia da Saúde do Porto.
Trial summary
The purpose of the present study was to evaluate the effects of one session of aerobic exercise associated with low level laser therapy in lipolytic activity, lipid profile and inflammatory markers (C-reactive protein - CRP). Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Disease
- What is being tested?
- Low level laser therapy, Aerobic Exercise and Low level laser therapy without power
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2016to 20 Jun 2017
- 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 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 25 years.
- BMI between 18,5Kg/m2 and 29,9Kg/m2
- consider presenting abdominal fat
Who cannot join
- pregnant or intending to be in a period of 9 months
- participants with smoking habits
- participants with neoplasias, metabolic dysfunctions, renal pathologies, dermatological alterations
- participants with electronic devices
- participants with a condition that makes it impossible to practice physical exercise (disabling skeletal muscle pathologies and severe cardiorespiratory pathologies)
- participants under the effect of beta-blockers or other drugs which influence heart rate
- participants submitted to other fat reduce procedure
About this study
Official title: Effect of Aerobic Exercise Associated With Abdominal Laser Therapy in Lipolytic Activity, Profile and Inflammatory Markers
The purpose of the present study was to evaluate the effects of one session of aerobic exercise associated with low level laser therapy in lipolytic activity, lipid profile and inflammatory markers (C-reactive protein - CRP).
Read the detailed description
The adipose tissue is the main energetic reserve, being constituted by adipocytes, cells that accumulate lipids inside its cytoplasm, in the form of triglycerides.
Fat deposition can occur both in the subcutaneous compartment and in the visceral compartment and is the result of a positive energy balance in which there is an imbalance between the amount of calories consumed and the amount of calories expended. Thus, an excess of energy storage occurs in the form of triglycerides in adipose tissue, which results from a sedentary lifestyle and a diet based on lipid rich nutrients. When fat deposition occurs in abdominal adipose tissue may favor the development of metabolic disorders.
Recently the effectiveness of an innovative physiotherapeutic intervention - low power laser therapy (LLLT) - on adipose tissue has been studied. This therapeutic modality stimulates cytochrome C oxidase, causing the release of nitric oxide, increased mitochondrial membrane potential and adenosine triphosphate (ATP) synthesis and the transient increase of reactive oxygen species (ROS). It is proposed that ROS creates temporary pores in the adipocyte membrane, allowing the release of its lipid content. It is also suggested that a regulation of cAMP occurs, which stimulates the lipolytic cascade, converting the triglycerides to fatty acids and glycerol. In this way, low level laser therapy seems to aid in the reduction of adiposity and in the decrease of cholesterol and triglycerides serum levels . In addition, it assists in the reduction of the inflammatory process related to obesity, by reducing the pro-inflammatory cytokines.
The aerobic exercise, due to its low-moderate intensity, enhances the stimulation of lipolysis, by decreasing plasma insulin concentration and elevating the level of catecholamines. In this way, it influences the lipid metabolism, seeming to improve the lipid profile, through the degradation of the triglycerides as energetic substrate. In addition, the regular practice of physical exercise seems to promote a decrease in the inflammation state due to metabolic changes, through the reduction of pro-inflammatory cytokines, namely interleukin-6 and, consequently, C-reactive protein.
The application of low level laser therapy in the abdominal region enhances the release of fat acids and glycerol into the bloodstream, increasing the availability of the substrate for muscle energy consumption. However, if they are not used as energy, free circulating fat acids may bind to glycerol and potentiate, again, the accumulation of triglycerides in abdominal adipocytes. Thus, aerobic exercise seems to be a good option in the fight against this re-esterification, since it is expected that the resulting fat acids will be converted to acetyl-CoA, entering the Krebs cycle, being used as energy source during aerobic exercise.
- Conditions
- Metabolic Disease
- Being tested
- Low level laser therapy, Aerobic Exercise, Low level laser therapy without power
- Keywords
- Aerobic Exercise, Lipolytic Laser, Lipid Profile, C-reactive protein, Lipolysis
- Medical subject headings
- Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low level laser therapyDevice
Low level laser therapy protocol - The low level laser therapy protocol was performed in dorsal decubitus, with the head elevated at 45º. The electrodes were placed in line, in the abdominal region. The low level laser therapy device has a length of about 940nm, using 8 pads, which have 64 diodes, each one with 100mW. The duration of the application was established in 8 minutes.
Aerobic ExerciseDevice
Aerobic exercise protocol - 50 minutes of aerobic moderate-intensity exercise (45-55% of reserve heart rate) using Karvonen´s formula, performed on a cycloergometer. The duration of the exercise was divided into three parts: warm-up (from 0 to 5 minutes); body (from 5 to 45 minutes); and cooling (from 45 to 50 minutes). The entire protocol was monitored through the Polar® brand cardiofrequency and watch.
Low level laser therapy without powerDevice
Low level laser therapy protocol - The low level laser therapy protocol was performed in dorsal decubitus, with the head elevated at 45º. The electrodes were placed in line, in the abdominal region. The low level laser therapy device has a length of about 940nm, using 8 pads, which have 64 diodes, each one with 100mW. The duration of the application was established in 8 minutes. In this group low level laser therapy device was switched off.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1 | Experimental | This group performed aerobic exercise just after low level laser therapy in the abdominal region with eight electrodes distributed in line. Receives: Device: Low level laser therapy; Device: Aerobic Exercise |
| Experimental group 2 | Experimental | This group performed aerobic exercise just after low level laser therapy in the abdominal region with eight electrodes distributed in line, but low level laser therapy device was switched off. Receives: Device: Aerobic Exercise; Device: Low level laser therapy without power |
| Placebo group | Placebo comparator | Low level laser therapy without power. This group performed the low level laser therapy protocol, but low level laser therapy device was switched off. Receives: Device: Low level laser therapy without power |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycerol concentration
Blood analysis collection was carried out with help from an clinical analysis technician.
Measured: 10 minutes before the intervention and 5 minutes after the intervention
Change in CRP concentration
Blood analysis collection was carried out with help from an clinical analysis technician.
Measured: 10 minutes before the intervention and 5 minutes after the intervention
Change in lipid profile (LDL, HDL and triglyceride concentrations)
Blood analysis collection was carried out with help from an clinical analysis technician.
Measured: 10 minutes before the intervention and 5 minutes after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start20 Nov 2016
- Primary completion20 May 2017
- Study completion20 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Metabolic DiseaseStudies 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
- 36 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462537
- Sponsor's protocol ID
- AN-006
- Status last verified
- Mar 2018
- First submitted
- 6 Mar 2018
- Last updated
- 12 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Afrooz PN, Pozner JN, DiBernardo BE. Noninvasive and minimally invasive techniques in body contouring. Clin Plast Surg. 2014 Oct;41(4):789-804. doi: 10.1016/j.cps.2014.07.006.
PubMed 25283463Ahmadian 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 20025992Aquino Junior, A. E. (2012). Efeito do laser de baixa intensidade (830nm) associado ao exercício em ratos obesos exógenos. São Carlos: Universidade Federal de São Carlos
Aquino AE Jr, Sene-Fiorese M, Castro CA, Duarte FO, Oishi JC, Santos GC, Silva KA, Fabrizzi F, Moraes G, Matheus SM, Duarte AC, Bagnato VS, Parizotto NA. Can low-level laser therapy when associated to exercise decrease adipocyte area? J Photochem Photobiol B. 2015 Aug;149:21-6. doi: 10.1016/j.jphotobiol.2015.04.033. Epub 2015 May 20.
PubMed 26026683Avci P, Gupta A, Sadasivam M, Vecchio D, Pam Z, Pam N, Hamblin MR. Low-level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring. Semin Cutan Med Surg. 2013 Mar;32(1):41-52.
PubMed 24049929Avci P, Nyame TT, Gupta GK, Sadasivam M, Hamblin MR. Low-level laser therapy for fat layer reduction: a comprehensive review. Lasers Surg Med. 2013 Aug;45(6):349-57. doi: 10.1002/lsm.22153. Epub 2013 Jun 7.
PubMed 23749426Brown SA, Rohrich RJ, Kenkel J, Young VL, Hoopman J, Coimbra M. Effect of low-level laser therapy on abdominal adipocytes before lipoplasty procedures. Plast Reconstr Surg. 2004 May;113(6):1796-804; discussion 1805-6. doi: 10.1097/01.prs.0000117302.73214.1a.
PubMed 15114147da Silveira Campos RM, Damaso AR, Masquio DC, Aquino AE Jr, Sene-Fiorese M, Duarte FO, Tock L, Parizotto NA, Bagnato VS. Low-level laser therapy (LLLT) associated with aerobic plus resistance training to improve inflammatory biomarkers in obese adults. Lasers Med Sci. 2015 Jul;30(5):1553-63. doi: 10.1007/s10103-015-1759-9. Epub 2015 May 10.
PubMed 25958170Cavalheiro, C., Ferreira, A., & Assunção, F. (2012). O uso da eletrolipólise no tratamento da adiposidade localizada. Revisão integrativa. Ensaios e Ciência: Ciências Biológicas, Agrárias e da Saúde, 16(3), 157-165.
Costa, A., Eberlin, S., Jorge, A., Mendonça, J., Kalies, A., & Pereira, C. (2014). Clinical study to assess abdominal circumferential reduction after treatment with lowfrequency. Surgical And Cosmetic Dermatology, 6(4), 320-324.
Donges CE, Duffield R, Drinkwater EJ. Effects of resistance or aerobic exercise training on interleukin-6, C-reactive protein, and body composition. Med Sci Sports Exerc. 2010 Feb;42(2):304-13. doi: 10.1249/MSS.0b013e3181b117ca.
PubMed 20083961Elm CM, Wallander ID, Endrizzi B, Zelickson BD. Efficacy of a multiple diode laser system for body contouring. Lasers Surg Med. 2011 Feb;43(2):114-21. doi: 10.1002/lsm.21016.
PubMed 21384392de Ferranti S, Mozaffarian D. The perfect storm: obesity, adipocyte dysfunction, and metabolic consequences. Clin Chem. 2008 Jun;54(6):945-55. doi: 10.1373/clinchem.2007.100156. Epub 2008 Apr 24.
PubMed 18436717Glisezinski, & I. (2007). Mobilisation des lipides du tissu adipeux au cours de l'exercice physique. Science & Sports, 22(6), 280-285. doi:10.1016/j.scispo.2007.09.013
Horowitz JF. Fatty acid mobilization from adipose tissue during exercise. Trends Endocrinol Metab. 2003 Oct;14(8):386-92. doi: 10.1016/s1043-2760(03)00143-7.
PubMed 14516937
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Exercise Associated With Abdominal Laser Therapy in Lipolytic Activity, Profile and Inflammatory Markers
- ClinicalTrials.gov ID
- NCT03462537
- Acronym / sponsor ID
- AN-006
- Conditions
- Metabolic Disease
- Keywords
- Aerobic Exercise, Lipolytic Laser, Lipid Profile, C-reactive protein, Lipolysis
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Escola Superior de Tecnologia da Saúde do PortoUniversity, hospital or other
- Study start
- 20 Nov 2016 (actual)
- Primary completion
- 20 May 2017 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 12 Mar 2018 (actual)
- 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 the present study was to evaluate the effects of one session of aerobic exercise associated with low level laser therapy in lipolytic activity, lipid profile and inflammatory markers (C-reactive protein - CRP).
Detailed description
The adipose tissue is the main energetic reserve, being constituted by adipocytes, cells that accumulate lipids inside its cytoplasm, in the form of triglycerides.
Fat deposition can occur both in the subcutaneous compartment and in the visceral compartment and is the result of a positive energy balance in which there is an imbalance between the amount of calories consumed and the amount of calories expended. Thus, an excess of energy storage occurs in the form of triglycerides in adipose tissue, which results from a sedentary lifestyle and a diet based on lipid rich nutrients. When fat deposition occurs in abdominal adipose tissue may favor the development of metabolic disorders.
Recently the effectiveness of an innovative physiotherapeutic intervention - low power laser therapy (LLLT) - on adipose tissue has been studied. This therapeutic modality stimulates cytochrome C oxidase, causing the release of nitric oxide, increased mitochondrial membrane potential and adenosine triphosphate (ATP) synthesis and the transient increase of reactive oxygen species (ROS). It is proposed that ROS creates temporary pores in the adipocyte membrane, allowing the release of its lipid content. It is also suggested that a regulation of cAMP occurs, which stimulates the lipolytic cascade, converting the triglycerides to fatty acids and glycerol. In this way, low level laser therapy seems to aid in the reduction of adiposity and in the decrease of cholesterol and triglycerides serum levels . In addition, it assists in the reduction of the inflammatory process related to obesity, by reducing the pro-inflammatory cytokines.
The aerobic exercise, due to its low-moderate intensity, enhances the stimulation of lipolysis, by decreasing plasma insulin concentration and elevating the level of catecholamines. In this way, it influences the lipid metabolism, seeming to improve the lipid profile, through the degradation of the triglycerides as energetic substrate. In addition, the regular practice of physical exercise seems to promote a decrease in the inflammation state due to metabolic changes, through the reduction of pro-inflammatory cytokines, namely interleukin-6 and, consequently, C-reactive protein.
The application of low level laser therapy in the abdominal region enhances the release of fat acids and glycerol into the bloodstream, increasing the availability of the substrate for muscle energy consumption. However, if they are not used as energy, free circulating fat acids may bind to glycerol and potentiate, again, the accumulation of triglycerides in abdominal adipocytes. Thus, aerobic exercise seems to be a good option in the fight against this re-esterification, since it is expected that the resulting fat acids will be converted to acetyl-CoA, entering the Krebs cycle, being used as energy source during aerobic exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1 | Experimental | Device: Low level laser therapy, Device: Aerobic ExerciseThis group performed aerobic exercise just after low level laser therapy in the abdominal region with eight electrodes distributed in line. |
| Experimental group 2 | Experimental | Device: Aerobic Exercise, Device: Low level laser therapy without powerThis group performed aerobic exercise just after low level laser therapy in the abdominal region with eight electrodes distributed in line, but low level laser therapy device was switched off. |
| Placebo group | Placebo comparator | Device: Low level laser therapy without powerLow level laser therapy without power. This group performed the low level laser therapy protocol, but low level laser therapy device was switched off. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age between 18 and 25 years.
- BMI between 18,5Kg/m2 and 29,9Kg/m2
- consider presenting abdominal fat
Key exclusion criteria (7 listed)
- pregnant or intending to be in a period of 9 months
- participants with smoking habits
- participants with neoplasias, metabolic dysfunctions, renal pathologies, dermatological alterations
- participants with electronic devices
- participants with a condition that makes it impossible to practice physical exercise (disabling skeletal muscle pathologies and severe cardiorespiratory pathologies)
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 |
|---|---|---|
| Low level laser therapyLow level laser therapy protocol - The low level laser therapy protocol was performed in dorsal decubitus, with the head elevated at 45º. The electrodes were placed in line, in the abdominal region. The low level laser therapy device has a length of about 940nm, using 8 pads, which have 64 diodes, each one with 100mW. The duration of the application was established in 8 minutes. | Device | Experimental group 1 |
| Aerobic ExerciseAerobic exercise protocol - 50 minutes of aerobic moderate-intensity exercise (45-55% of reserve heart rate) using Karvonen´s formula, performed on a cycloergometer. The duration of the exercise was divided into three parts: warm-up (from 0 to 5 minutes); body (from 5 to 45 minutes); and cooling (from 45 to 50 minutes). The entire protocol was monitored through the Polar® brand cardiofrequency and watch. | Device | Experimental group 1, Experimental group 2 |
| Low level laser therapy without powerLow level laser therapy protocol - The low level laser therapy protocol was performed in dorsal decubitus, with the head elevated at 45º. The electrodes were placed in line, in the abdominal region. The low level laser therapy device has a length of about 940nm, using 8 pads, which have 64 diodes, each one with 100mW. The duration of the application was established in 8 minutes. In this group low level laser therapy device was switched off. | Device | Experimental group 2, Placebo group |
Primary outcome
Change in glycerol concentration
Time frame: 10 minutes before the intervention and 5 minutes after the intervention
Blood analysis collection was carried out with help from an clinical analysis technician.
Change in CRP concentration
Time frame: 10 minutes before the intervention and 5 minutes after the intervention
Blood analysis collection was carried out with help from an clinical analysis technician.
Change in lipid profile (LDL, HDL and triglyceride concentrations)
Time frame: 10 minutes before the intervention and 5 minutes after the intervention
Blood analysis collection was carried out with help from an clinical analysis technician.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Background: PubMed 25283463Afrooz PN, Pozner JN, DiBernardo BE. Noninvasive and minimally invasive techniques in body contouring. Clin Plast Surg. 2014 Oct;41(4):789-804. doi: 10.1016/j.cps.2014.07.006.
- 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.
- BackgroundAquino Junior, A. E. (2012). Efeito do laser de baixa intensidade (830nm) associado ao exercício em ratos obesos exógenos. São Carlos: Universidade Federal de São Carlos
- Background: PubMed 26026683Aquino AE Jr, Sene-Fiorese M, Castro CA, Duarte FO, Oishi JC, Santos GC, Silva KA, Fabrizzi F, Moraes G, Matheus SM, Duarte AC, Bagnato VS, Parizotto NA. Can low-level laser therapy when associated to exercise decrease adipocyte area? J Photochem Photobiol B. 2015 Aug;149:21-6. doi: 10.1016/j.jphotobiol.2015.04.033. Epub 2015 May 20.
- Background: PubMed 24049929Avci P, Gupta A, Sadasivam M, Vecchio D, Pam Z, Pam N, Hamblin MR. Low-level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring. Semin Cutan Med Surg. 2013 Mar;32(1):41-52.
- Background: PubMed 23749426Avci P, Nyame TT, Gupta GK, Sadasivam M, Hamblin MR. Low-level laser therapy for fat layer reduction: a comprehensive review. Lasers Surg Med. 2013 Aug;45(6):349-57. doi: 10.1002/lsm.22153. Epub 2013 Jun 7.
- Background: PubMed 15114147Brown SA, Rohrich RJ, Kenkel J, Young VL, Hoopman J, Coimbra M. Effect of low-level laser therapy on abdominal adipocytes before lipoplasty procedures. Plast Reconstr Surg. 2004 May;113(6):1796-804; discussion 1805-6. doi: 10.1097/01.prs.0000117302.73214.1a.
- Background: PubMed 25958170da Silveira Campos RM, Damaso AR, Masquio DC, Aquino AE Jr, Sene-Fiorese M, Duarte FO, Tock L, Parizotto NA, Bagnato VS. Low-level laser therapy (LLLT) associated with aerobic plus resistance training to improve inflammatory biomarkers in obese adults. Lasers Med Sci. 2015 Jul;30(5):1553-63. doi: 10.1007/s10103-015-1759-9. Epub 2015 May 10.
- BackgroundCavalheiro, C., Ferreira, A., & Assunção, F. (2012). O uso da eletrolipólise no tratamento da adiposidade localizada. Revisão integrativa. Ensaios e Ciência: Ciências Biológicas, Agrárias e da Saúde, 16(3), 157-165.
- BackgroundCosta, A., Eberlin, S., Jorge, A., Mendonça, J., Kalies, A., & Pereira, C. (2014). Clinical study to assess abdominal circumferential reduction after treatment with lowfrequency. Surgical And Cosmetic Dermatology, 6(4), 320-324.
- Background: PubMed 20083961Donges CE, Duffield R, Drinkwater EJ. Effects of resistance or aerobic exercise training on interleukin-6, C-reactive protein, and body composition. Med Sci Sports Exerc. 2010 Feb;42(2):304-13. doi: 10.1249/MSS.0b013e3181b117ca.
- Background: PubMed 21384392Elm CM, Wallander ID, Endrizzi B, Zelickson BD. Efficacy of a multiple diode laser system for body contouring. Lasers Surg Med. 2011 Feb;43(2):114-21. doi: 10.1002/lsm.21016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low level laser therapy, Aerobic Exercise and Low level laser therapy without power in people with Metabolic Disease, run by Escola Superior de Tecnologia da Saúde do Porto.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early. Results are not available in the source record.
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 glycerol concentration (time frame: 10 minutes before the intervention and 5 minutes after the intervention). 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 NCT03462537, which also lists 28 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 12 Mar 2018.