Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04477109 |
| Other study ID # |
P.T.REC/012/002677 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2020 |
| Est. completion date |
April 1, 2023 |
Study information
| Verified date |
May 2023 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 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
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?
