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

Primary Purpose

Insulin Resistance, Inflammatory Markers

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
low level laser in addition to diet recommendations
sham laser application in addition to diet recommendations
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Resistance

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

low level laser in addition to diet recommendations

sham laser application in addition to diet recommendations

Arm Description

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

while the control group will stick to the same line of treatment but with sham laser application

Outcomes

Primary Outcome Measures

insulin resistance
change of insulin resistance by Homeostatic Model Assessment of Insulin Resistance
inflammatory markers
change of inflammatory markers(C-reactive protein-erythrocyte sedimentation rate-White blood cells-lymphocytes)

Secondary Outcome Measures

body mass index
divide weight by height square

Full Information

First Posted
July 15, 2020
Last Updated
May 7, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04477109
Brief Title
Effectiveness of Low Level Laser Therapy on Insulin Resistance and Inflammatory Biomarkers
Official Title
Effectiveness of Low Level Laser Therapy on Insulin Resistance and Inflammatory Biomarkers in Obese Postmenopausal Breast Cancer Risk Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
April 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Inflammatory Markers

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low level laser in addition to diet recommendations
Arm Type
Active Comparator
Arm Description
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
Arm Title
sham laser application in addition to diet recommendations
Arm Type
Sham Comparator
Arm Description
while the control group will stick to the same line of treatment but with sham laser application
Intervention Type
Device
Intervention Name(s)
low level laser in addition to diet recommendations
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
sham laser application in addition to diet recommendations
Intervention Description
sham laser application in addition to diet recommendations
Primary Outcome Measure Information:
Title
insulin resistance
Description
change of insulin resistance by Homeostatic Model Assessment of Insulin Resistance
Time Frame
12 weeks
Title
inflammatory markers
Description
change of inflammatory markers(C-reactive protein-erythrocyte sedimentation rate-White blood cells-lymphocytes)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
body mass index
Description
divide weight by height square
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
marwa m elsayed, phd
Organizational Affiliation
lecturer at physical therapy faculty cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physical Therapy
City
Cairo
ZIP/Postal Code
11432
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://Scholar.cu.edu.eg/p_t

Learn more about this trial

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

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