Fatty Liver, NonalcoholicNCT04452409
Enhanced Liver Function in Non-alcoholic Obese Fatty Liver Patients by Low Level Laser Therapy
A study testing low level laser and Mediterranean diet in people with Fatty Liver, Nonalcoholic and Liver Function, run by Cairo University at 1 site in Egypt.
Trial summary
Non-alcoholic fatty liver disease is excessive fat build-up in the liver with insulin resistance due to causes other than alcohol use.The obesity epidemic is closely associated with the rising prevalence and severity of nonalcoholic fatty liver disease.Currently, the only treatment modality for patients with fatty… Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Fatty Liver, Nonalcoholic, Liver Function
- What is being tested?
- low level laser and Mediterranean diet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Jan 2020to 1 Sep 2021
- Phase
- Interventional
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Sixty non-alcoholic fatty liver patients aged from 60-75 y
- Body mass index (BMI) ranged from 30 to 34.9 kg/m2
- Elevated triglyceride \& LDL levels
- Higher Risk Waist Circumference Measurements (Men: 40 or more inches or 102 centimeters or more/ Women: 35 or more inches or 89 centimeters or more)
- Elevated aminoalanine transaminase (ALT) level, defined as 20 or more Unites/Liter (U/L) above the normal gender-specific ALT levels: males: ALT ≥ 60 U/L; females: ALT ≥ 50 U/L
- Review of subject's pre-existing medical records to confirm the current diagnosis of nonalcoholic fatty liver according to the following criteria:
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- ALT elevated on two separate determinations
- Abdominal ultrasound showing fatty liver
- Blood work that excludes other potential etiologies of liver disease
- Subject agrees to maintain his or her diet regimen throughout study participation
Who cannot join
- • History of cardiovascular disease or events including, but not limited to, coronary artery disease, valvular heart disease, cardiac arrhythmias, congestive heart failure, myocardial infarction, stroke, transient ischemic attack, or peripheral vascular disease
- Cardiac surgeries or procedures, including but not limited to, coronary artery bypass surgery or stent placement, heart transplantation, pacemaker insertion or implantation of a defibrillator
- An implanted device in the target area to receive low level laser light therapy (e.g. pain pump, lap band, penile inflation device, ventriculo-peritoneal shunts, etc.)
- Known photosensitivity disorder
- Current active cancer or within one year of cancer treatment or remission
- Excessive alcohol consumption defined as 14 or more alcoholic drinks per week
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- Serious mental health illness that in the opinion of the investigator would preclude the subject from study participation
- Active infection, wound or other external trauma to the target area to receive the laser therapy
- Developmental disability or cognitive impairment that in the opinion of the investigator would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements
- Participation in a clinical study or other type of research in the past 30 days
Trial locations and contacts
1 site in 1 country.
About this study
Non-alcoholic fatty liver disease is excessive fat build-up in the liver with insulin resistance due to causes other than alcohol use.The obesity epidemic is closely associated with the rising prevalence and severity of nonalcoholic fatty liver disease.Currently, the only treatment modality for patients with fatty liver disease is weight loss and exercise which is challenging for most patients. Therefore, a huge need exists for an alternative approach to reducing alanine transaminase (ALT) \& aspartate aminotransferase (AST) levels for these patients. Low level laser light therapy (LLLT) offers a simple, non-invasive, safe, effective and side-effect free alternative to achieving this goal, through LLLT's proven ability to effect weight loss, body circumference reduction and lipid profile modification
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) is a very common disorder and refers to a group of conditions where there is accumulation of excess fat in the liver of people who drink little or no alcohol. The most common form of NAFLD is a non serious condition called fatty liver.
NAFLD is part of the metabolic syndrome characterized by diabetes, or pre-diabetes (insulin resistance), being overweight or obese, elevated blood lipids such as cholesterol and triglycerides, as well as high blood pressure. A few studies have suggested that weight loss may be associated with regression of fat within the liver. Therefore, the most important recommendations for people with fatty liver are to lose weight if they are overweight or obese, increase their physical activity, follow a balanced diet and unnecessary medications.
Several studies have investigated low-level laser therapy (LLLT) or light-emitting diode (LED) therapy and have made advances in the understanding of the underlying mechanisms LLLT in biological systems. Few studies explain the effect of low level laser therapy on liver enzymes and non alcoholic fatty liver risk factors (as obesity).So, our goal was to perform a randomized controlled trial to investigate the effects of the LLLT on lipid profile, body weight and liver enzymes
- Conditions
- Fatty Liver, Nonalcoholic, Liver Function
- Being tested
- low level laser, Mediterranean diet
- Keywords
- low level laser
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laserDevice
The laser therapy device (660 nm) consisted of abdominal straps containing 4 LED clusters, having 72 LEDs each, applied in the study group paticipants around the patients abdomen and waist after cleaning the target area and wearing safety goggles20, for 30 min., 2 times per week over 12 weeks
Mediterranean dietOther
recommend healthy diet component evaluated periodically by 24 hour recall
| Study group | Role | What they receive |
|---|---|---|
| study (low level laser plus Mediterranean diet) | Active comparator | Active infra -red laser in addition to diet Receives: Device: low level laser; Other: Mediterranean diet |
| control (Mediterranean diet only) | Other | diet Receives: Other: Mediterranean diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in liver function
measuring liver enzymes (alanine transaminase (ALT) \& aspartate aminotransferase (AST) ) and alkaline phosphate before and after low level laser application and the prescribed diet recommendations
Measured: 3 months
Secondary outcomes (3)
changes of lipid profile
measuring effect of low level laser application in addition to diet recommendations on lipid profile (low density lipoprotein LDL, high density lipoprotein HDL, total cholesterol T.C and triglyceride T.G)
Measured: 3 months
changes of Body Mass Index
measuring effect of low level laser application in addition to diet recommendations on body mass index (weight by Kg / height per meter square)
Measured: 3 months
changes of waist circumference
measuring effect of low level laser application in addition to diet recommendations on waist circumference
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start10 Jan 2020
- Primary completion25 Jul 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty Liver, NonalcoholicStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebtesam Nabil, Cairo University
- Investigators
- Ebtesam Nabil, doctoral, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452409
- Sponsor's protocol ID
- P.T.REC/012/002722
- Status last verified
- Sep 2021
- First submitted
- 25 Jun 2020
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Liver Function in Non-alcoholic Obese Fatty Liver Patients by Low Level Laser Therapy
- ClinicalTrials.gov ID
- NCT04452409
- Acronym / sponsor ID
- P.T.REC/012/002722
- Conditions
- Fatty Liver, Nonalcoholic, Liver Function
- Keywords
- low level laser
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 25 Jul 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 30 Jun 2020 (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-alcoholic fatty liver disease is excessive fat build-up in the liver with insulin resistance due to causes other than alcohol use.The obesity epidemic is closely associated with the rising prevalence and severity of nonalcoholic fatty liver disease.Currently, the only treatment modality for patients with fatty liver disease is weight loss and exercise which is challenging for most patients. Therefore, a huge need exists for an alternative approach to reducing alanine transaminase (ALT) \& aspartate aminotransferase (AST) levels for these patients. Low level laser light therapy (LLLT) offers a simple, non-invasive, safe, effective and side-effect free alternative to achieving this goal, through LLLT's proven ability to effect weight loss, body circumference reduction and lipid profile modification
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is a very common disorder and refers to a group of conditions where there is accumulation of excess fat in the liver of people who drink little or no alcohol. The most common form of NAFLD is a non serious condition called fatty liver.
NAFLD is part of the metabolic syndrome characterized by diabetes, or pre-diabetes (insulin resistance), being overweight or obese, elevated blood lipids such as cholesterol and triglycerides, as well as high blood pressure. A few studies have suggested that weight loss may be associated with regression of fat within the liver. Therefore, the most important recommendations for people with fatty liver are to lose weight if they are overweight or obese, increase their physical activity, follow a balanced diet and unnecessary medications.
Several studies have investigated low-level laser therapy (LLLT) or light-emitting diode (LED) therapy and have made advances in the understanding of the underlying mechanisms LLLT in biological systems. Few studies explain the effect of low level laser therapy on liver enzymes and non alcoholic fatty liver risk factors (as obesity).So, our goal was to perform a randomized controlled trial to investigate the effects of the LLLT on lipid profile, body weight and liver enzymes
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study (low level laser plus Mediterranean diet) | Active comparator | Device: low level laser, Other: Mediterranean dietActive infra -red laser in addition to diet |
| control (Mediterranean diet only) | Other | Other: Mediterranean dietdiet |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- • Sixty non-alcoholic fatty liver patients aged from 60-75 y
Key exclusion criteria (10 listed)
- • History of cardiovascular disease or events including, but not limited to, coronary artery disease, valvular heart disease, cardiac arrhythmias, congestive heart failure, myocardial infarction, stroke, transient ischemic attack, or peripheral vascular disease
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 |
|---|---|---|
| low level laserThe laser therapy device (660 nm) consisted of abdominal straps containing 4 LED clusters, having 72 LEDs each, applied in the study group paticipants around the patients abdomen and waist after cleaning the target area and wearing safety goggles20, for 30 min., 2 times per week over 12 weeks | Device | study (low level laser plus Mediterranean diet) |
| Mediterranean dietrecommend healthy diet component evaluated periodically by 24 hour recall | Other | control (Mediterranean diet only), study (low level laser plus Mediterranean diet) |
Primary outcome
changes in liver function
Time frame: 3 months
measuring liver enzymes (alanine transaminase (ALT) \& aspartate aminotransferase (AST) ) and alkaline phosphate before and after low level laser application and the prescribed diet recommendations
3 secondary outcomes
changes of lipid profile
Time frame: 3 months
changes of Body Mass Index
Time frame: 3 months
changes of waist circumference
Time frame: 3 months
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 28 Sep 2021.
- Individual participant dataSharing planned: Yes
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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.
Ebtesam Nabil, doctoral principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low level laser and Mediterranean diet in people with Fatty Liver, Nonalcoholic and Liver Function, 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 10 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 28 Sep 2021. 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?
changes in liver function (time frame: 3 months). 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 28 Sep 2021.