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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06193746
Other study ID # P.T.REC/012/004441
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 10, 2023
Est. completion date October 10, 2023

Study information

Verified date December 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date October 10, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 45 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Toka Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

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