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

NCT04477109 | Completed

• 1 other identifier: P.T.REC/012/002677
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Insulin Resistance; Inflammatory Markers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• body mass index

  12 weeks

Study Arms (2)

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

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

Other: sham laser application in addition to diet recommendations

Interventions

low level laser in addition to diet recommendations DEVICE

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

low level laser in addition to diet recommendations

sham laser application in addition to diet recommendations OTHER

sham laser application in addition to diet recommendations

sham laser application in addition to diet recommendations

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sixty Postmenopausal women (60-75 y)
• Body mass index (BMI) ranged from 30 to 34.9 kg/m2
• Family history of breast cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Physical Therapy

Cairo, 11432, Egypt

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• marwa m elsayed, phd

  lecturer at physical therapy faculty cairo university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: July 15, 2020
• First Posted: July 20, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: April 1, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: one year after completing the study
• Access Criteria: journal publishing the study

Locations

EG (1)