Insulin ResistanceNCT04477109
Effectiveness of Low Level Laser Therapy on Insulin Resistance and Inflammatory Biomarkers
A study testing low level laser in addition to diet recommendations in people with Insulin Resistance and Inflammatory Markers, run by Cairo University at 1 site in Egypt.
Trial summary
It is an interventional study in which 60 women estimated to enroll according to random allocation and assigned into two groups equal. The study group will receive active low level laser in addition to diet recommendations while the control group will stick to the same line of treatment but with sham laser… Read more about this study
- Who is it for?
- Ages 60 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Inflammatory Markers
- What is being tested?
- low level laser in addition to diet recommendations
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2020to 1 Apr 2023
- 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 60 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • Sixty Postmenopausal women (60-75 y)
- Body mass index (BMI) ranged from 30 to 34.9 kg/m2
- Family history of breast cancer
Who cannot join
- • women receiving weight-reduction interventions
- taking lipid lowering drugs
- regular medications(e.g., β-blockers, α-blockers, digoxin, diuretics, aspirin, nitrates, or hormones)
- having active chronic illness (e.g., rheumatoid arthritis, hyperthyroidism, and inflammatory bowel disease)
- cognitive impairment that will make it difficult to partake in the study
- presence of malignant disease
- blood donation within the last 30 days
- Participation as a subject in any type of study or research during the prior 90 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Low Level Laser Therapy on Insulin Resistance and Inflammatory Biomarkers in Obese Postmenopausal Breast Cancer Risk Women
It is an interventional study in which 60 women estimated to enroll according to random allocation and assigned into two groups equal. The study group will receive active low level laser in addition to diet recommendations while the control group will stick to the same line of treatment but with sham laser application. The laser consists of semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt, but it can also be adjusted. The device operates at an ambient temperature of -20 to +40 ° C and a relative humidity of ≤ 85%. The laser watch can be used for a variable irradiation period of 10-60 min. the device will be applied on specific acupuncture points (N acupuncture point, Radial artery acupuncture points, and ulnar artery acupuncture points) combined with nasal laser irradiation at the same time, once per day, 3 times per week for three months
Read the detailed description
PURPOSE:
To determine the effectiveness of low level laser therapy on insulin resistance and inflammatory biomarkers in obese postmenopausal breast cancer risk women
BACKGROUND:
The American Obesity Association (2002, 2003) defines obesity as 'a complex, multifactorial chronic disease involving environmental (social and cultural), genetic, physiologic, metabolic, behavioral, and psychological components'. However, the most commonly used definitions of obesity are based on BMI, which is defined as weight in kilograms divided by height in meters squared. In adults, obesity is generally defined as a BMI of 30.0 or greater. Obesity has become a major contributor to the global burden of chronic disease and disability. It is a complex condition with serious social and psychological dimensions, affecting virtually all ages and socioeconomic group Obesity is associated with an increased risk of developing insulin resistance and type 2 diabetes. In obese individuals, adipose tissue releases increased amounts of non-esterified fatty acids, glycerol, hormones, proinflammatory cytokines and other factors that are involved in the development of insulin resistance. In overweight and obesity, there exists low-grade chronic inflammation characterized by the increase of cytokines and serum concentrations such as fibrinogen and C-reactive protein (CRP) The areas of low - intensity laser use have expanded in several conditions by different mechanisms and ways. LLLT has been used as an important tool for the control of the inflammatory process. Its anti-inflammatory effect has been studied and its ability to induce analgesia under different conditions has also been reported. Because laser acupuncture appears to be safe, it could be considered as a complementary form of palliative care for prevention of cancer risk, especially for clinical problems for which conventional care options are limited. Investigations suggest the benefits of low-level laser therapy (LLLT) to improve noninvasive body contouring treatments, inflammation, insulin resistance and to reduce body fat.
HYPOTHESES:
Low level laser therapy in form of laser watch has no effect on insulin resistance inflammatory biomarkers in obese postmenopausal breast cancer risk women
RESEARCH QUESTION:
Does low level laser therapy has an effect on insulin resistance inflammatory biomarkers in obese postmenopausal breast cancer risk women?
- Conditions
- Insulin Resistance, Inflammatory Markers
- Being tested
- low level laser in addition to diet recommendations, sham laser application in addition to diet recommendations
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser in addition to diet recommendationsDevice
The laser consists of a semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt
sham laser application in addition to diet recommendationsOther
sham laser application in addition to diet recommendations
| Study group | Role | What they receive |
|---|---|---|
| low level laser in addition to diet recommendations | Active comparator | The laser consists of a semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt, but it can also be adjusted. The device operates at an ambient temperature of -20 to +40 ° C and a relative humidity of ≤ 85%. The laser watch can be used for a variable irradiation period of 10-60 min. the device will be applied on specific acupuncture points (N acupuncture point, Radial artery acupuncture points, and ulnar artery acupuncture points) combined with nasal laser irradiation at the same time, once per day, 3 times per week for three months Receives: Device: low level laser in addition to diet recommendations |
| sham laser application in addition to diet recommendations | Sham comparator | while the control group will stick to the same line of treatment but with sham laser application Receives: Other: sham laser application in addition to diet recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin resistance
change of insulin resistance by Homeostatic Model Assessment of Insulin Resistance
Measured: 12 weeks
inflammatory markers
change of inflammatory markers(C-reactive protein-erythrocyte sedimentation rate-White blood cells-lymphocytes)
Measured: 12 weeks
Secondary outcomes (1)
body mass index
divide weight by height square
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2022
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa mahmoud elsayed mahmoud, Cairo University
- Investigators
- marwa m elsayed, phd, Principal investigator, lecturer at physical therapy faculty cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477109
- Sponsor's protocol ID
- P.T.REC/012/002677
- Status last verified
- May 2023
- First submitted
- 15 Jul 2020
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Low Level Laser Therapy on Insulin Resistance and Inflammatory Biomarkers in Obese Postmenopausal Breast Cancer Risk Women
- ClinicalTrials.gov ID
- NCT04477109
- Acronym / sponsor ID
- P.T.REC/012/002677
- Conditions
- Insulin Resistance, Inflammatory Markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 20 Jul 2020 (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.
It is an interventional study in which 60 women estimated to enroll according to random allocation and assigned into two groups equal. The study group will receive active low level laser in addition to diet recommendations while the control group will stick to the same line of treatment but with sham laser application. The laser consists of semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt, but it can also be adjusted. The device operates at an ambient temperature of -20 to +40 ° C and a relative humidity of ≤ 85%. The laser watch can be used for a variable irradiation period of 10-60 min. the device will be applied on specific acupuncture points (N acupuncture point, Radial artery acupuncture points, and ulnar artery acupuncture points) combined with nasal laser irradiation at the same time, once per day, 3 times per week for three months
Detailed description
PURPOSE:
To determine the effectiveness of low level laser therapy on insulin resistance and inflammatory biomarkers in obese postmenopausal breast cancer risk women
BACKGROUND:
The American Obesity Association (2002, 2003) defines obesity as 'a complex, multifactorial chronic disease involving environmental (social and cultural), genetic, physiologic, metabolic, behavioral, and psychological components'. However, the most commonly used definitions of obesity are based on BMI, which is defined as weight in kilograms divided by height in meters squared. In adults, obesity is generally defined as a BMI of 30.0 or greater. Obesity has become a major contributor to the global burden of chronic disease and disability. It is a complex condition with serious social and psychological dimensions, affecting virtually all ages and socioeconomic group Obesity is associated with an increased risk of developing insulin resistance and type 2 diabetes. In obese individuals, adipose tissue releases increased amounts of non-esterified fatty acids, glycerol, hormones, proinflammatory cytokines and other factors that are involved in the development of insulin resistance. In overweight and obesity, there exists low-grade chronic inflammation characterized by the increase of cytokines and serum concentrations such as fibrinogen and C-reactive protein (CRP) The areas of low - intensity laser use have expanded in several conditions by different mechanisms and ways. LLLT has been used as an important tool for the control of the inflammatory process. Its anti-inflammatory effect has been studied and its ability to induce analgesia under different conditions has also been reported. Because laser acupuncture appears to be safe, it could be considered as a complementary form of palliative care for prevention of cancer risk, especially for clinical problems for which conventional care options are limited. Investigations suggest the benefits of low-level laser therapy (LLLT) to improve noninvasive body contouring treatments, inflammation, insulin resistance and to reduce body fat.
HYPOTHESES:
Low level laser therapy in form of laser watch has no effect on insulin resistance inflammatory biomarkers in obese postmenopausal breast cancer risk women
RESEARCH QUESTION:
Does low level laser therapy has an effect on insulin resistance inflammatory biomarkers in obese postmenopausal breast cancer risk women?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low level laser in addition to diet recommendations | Active comparator | Device: low level laser in addition to diet recommendationsThe laser consists of a semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt, but it can also be adjusted. The device operates at an ambient temperature of -20 to +40 ° C and a relative humidity of ≤ 85%. The laser watch can be used for a variable irradiation period of 10-60 min. the device will be applied on specific acupuncture points (N acupuncture point, Radial artery acupuncture points, and ulnar artery acupuncture points) combined with nasal laser irradiation at the same time, once per day, 3 times per week for three months |
| sham laser application in addition to diet recommendations | Sham comparator | Other: sham laser application in addition to diet recommendationswhile the control group will stick to the same line of treatment but with sham laser application |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- • Sixty Postmenopausal women (60-75 y)
Key exclusion criteria (8 listed)
- • women receiving weight-reduction interventions
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 in addition to diet recommendationsThe laser consists of a semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt | Device | low level laser in addition to diet recommendations |
| sham laser application in addition to diet recommendationssham laser application in addition to diet recommendations | Other | sham laser application in addition to diet recommendations |
Primary outcome
insulin resistance
Time frame: 12 weeks
change of insulin resistance by Homeostatic Model Assessment of Insulin Resistance
inflammatory markers
Time frame: 12 weeks
change of inflammatory markers(C-reactive protein-erythrocyte sedimentation rate-White blood cells-lymphocytes)
1 secondary outcome
body mass index
Time frame: 12 weeks
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 9 May 2023.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for Insulin Resistance
Active, not recruiting
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Insulin Resistance, Obesity
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
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Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
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.
marwa m elsayed, phd principal investigator
lecturer at physical therapy faculty cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low level laser in addition to diet recommendations in people with Insulin Resistance and Inflammatory Markers, run by Cairo University at 1 site in Egypt.
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 8 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 9 May 2023. 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 Egypt. 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?
insulin resistance (time frame: 12 weeks). 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?
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 9 May 2023.