Metabolic SyndromeNCT06193746
Laser Efficiency on Metabolic Parameters
An observational study of Metabolic Syndrome, run by Cairo University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- non-invasive laser therapy
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2023to 10 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: the study population selected from out patient of Berket El-haje medical center suffering from metabolic syndrome
Who may be able to join
- 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.
Who cannot join
- taking specific drugs uncontrolled diseases
- cardiovascular instability
- sever e autonomic neuropathy
- infection wound,
- burn, allergy or another external injury
- hypothyroidism
Show all 10Show fewer
- hemorrhagic disorders
- history of cancer
- pregnant women,
- mental illness as schizophrenia or dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- non-invasive laser therapy
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive laser therapyDevice
Also called laser watch
(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
| Study group | Role | What they receive |
|---|---|---|
| study group | wear the laser watch on wrist 3times/weak up to 30 minute for 12 weeks , Receives: Device: non-invasive laser therapy | |
| control group | taking advises only |
What is being measured
The primary outcome is the main question the study is designed to answer.
lipid profile change
laboratorial measurement of lipid in one mg/dl of blood
Measured: 12 weeks following end of treatment
glomerular function range change
laboratorial measurement of glomerular function range in one ml of blood/1minute/1.73m2
Measured: 12 weeks following end of treatment
creatinine change
laboratorial measurement of creatinine one mg/DL of blood
Measured: 12 weeks following end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start10 Apr 2023
- Primary completion30 Jun 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Elbanna, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06193746
- Sponsor's protocol ID
- P.T.REC/012/004441
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-invasive on Lipid Metabolism and Renal Out Comes in Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT06193746
- Acronym / sponsor ID
- P.T.REC/012/004441
- Conditions
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Device: non-invasive laser therapywear the laser watch on wrist 3times/weak up to 30 minute for 12 weeks , |
| control group | – | –taking advises only |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- the study population selected from out patient of Berket El-haje medical center suffering from metabolic syndrome
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- taking specific drugs uncontrolled diseases
- cardiovascular instability
- sever e autonomic neuropathy
- infection wound,
- burn, allergy or another external injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-invasive laser therapyAlso: laser watch(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 | Device | study group |
Primary outcome
lipid profile change
Time frame: 12 weeks following end of treatment
laboratorial measurement of lipid in one mg/dl of blood
glomerular function range change
Time frame: 12 weeks following end of treatment
laboratorial measurement of glomerular function range in one ml of blood/1minute/1.73m2
creatinine change
Time frame: 12 weeks following end of treatment
laboratorial measurement of creatinine one mg/DL of blood
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lipid profile change (time frame: 12 weeks following end of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.