Laser Efficiency on Metabolic Parameters

Effect of Non-invasive on Lipid Metabolism and Renal Out Comes in Metabolic Syndrome

Non-invasive laser therapy is laser blood irradiation improves many metabolic parameters. So, this study aims to assess the impact of Non-invasive laser therapy on lipid metabolism and renal out comes

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Device: non-invasive laser therapy

Detailed Description

The metabolic syndrome is a constellation of interrelated metabolic risk factors especially central obesity, dyslipidemia, hyperglycemia, which all affect worse their kidney function, and all of this causing mortality. This time line requires a quick procedure that will enable us to implement safe and non-invasive therapeutic instruments adjacent therapy for metabolic syndrome cases.

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Toka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

the study population selected from out patient of Berket El-haje medical center suffering from metabolic syndrome

Description

Inclusion Criteria:

• The patients have Metabolic syndrome, started more than one year ago.
• BMI ranged 30- 35Kg/m2.
• They are on medical therapy for more than one year.
• Clinically stable.

Exclusion Criteria:

• taking specific drugs uncontrolled diseases
• cardiovascular instability
• sever e autonomic neuropathy
• infection wound,
• burn, allergy or another external injury
• hypothyroidism
• hemorrhagic disorders
• history of cancer
• pregnant women,
• mental illness as schizophrenia or dementia.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
study group; wear the laser watch on wrist 3times/weak up to 30 minute for 12 weeks ,	Device: non-invasive laser therapy; (diode laser, continuous output, in skin contact mode, 0.005W,0.2cm,beam spot area 0.03cm2, 288j/cm ,1800s) in the morning session, we measured lipid profile and kidney function before and after treatment to measure improvement; Other Names: laser watch
control group; taking advises only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lipid profile change	laboratorial measurement of lipid in one mg/dl of blood	12 weeks following end of treatment
glomerular function range change	laboratorial measurement of glomerular function range in one ml of blood/1minute/1.73m2	12 weeks following end of treatment
creatinine change	laboratorial measurement of creatinine one mg/DL of blood	12 weeks following end of treatment

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): October 10, 2023

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: P.T.REC/012/004441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No