NCT06193746

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

January 5, 2024

Completed
Last Updated

January 5, 2024

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

December 11, 2023

Last Update Submit

December 21, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

study group

wear the laser watch on wrist 3times/weak up to 30 minute for 12 weeks ,

Device: non-invasive laser therapy

control group

taking advises only

Interventions

(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

Also known as: laser watch
study group

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toka

Cairo, Egypt

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer cardiovascular, Respiratory disorder and geriatric department,

Study Record Dates

First Submitted

December 11, 2023

First Posted

January 5, 2024

Study Start

April 10, 2023

Primary Completion

June 30, 2023

Study Completion

October 10, 2023

Last Updated

January 5, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations