Effectiveness of Low Level Laser Therapy on Insulin Resistance and Inflammatory Biomarkers

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

Study Overview

• Status: Completed
• Conditions: Insulin Resistance; Inflammatory Markers
• Intervention / Treatment: Device: low level laser in addition to diet recommendations; Other: sham laser application in addition to diet recommendations

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: marwa M elsayed, phd; Phone Number: 02 01156033818; Email: marwadd999@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 11432
    • Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• • Sixty Postmenopausal women (60-75 y)

  • Body mass index (BMI) ranged from 30 to 34.9 kg/m2
  • Family history of breast cancer

Exclusion Criteria:

• • 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: low level laser in addition to diet recommendations; 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	Device: low level laser in addition to diet recommendations; 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 Comparator: sham laser application in addition to diet recommendations; while the control group will stick to the same line of treatment but with sham laser application	Other: sham laser application in addition to diet recommendations; sham laser application in addition to diet recommendations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insulin resistance	change of insulin resistance by Homeostatic Model Assessment of Insulin Resistance	12 weeks
inflammatory markers	change of inflammatory markers(C-reactive protein-erythrocyte sedimentation rate-White blood cells-lymphocytes)	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
body mass index	divide weight by height square	12 weeks

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: marwa m elsayed, phd, lecturer at physical therapy faculty cairo university

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: July 15, 2020
• First Submitted That Met QC Criteria: July 15, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 7, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: P.T.REC/012/002677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all IPD that underlie results in a publication
• IPD Sharing Time Frame: one year after completing the study
• IPD Sharing Access Criteria: journal publishing the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No