PsoriasisNCT05125757
Lifestyle Modification in Psoriatic Patients With Fatty Liver
A study testing lifestyle modification and usual lifestyle in people with Psoriasis and Fatty Liver, run by Cairo University at 1 site in Egypt.
Trial summary
Several recent reports have shown an increased prevalence of nonalcoholic fatty liver disease (NAFLD) in those with psoriasis, which may reflect the increased occurrence of metabolic syndrome in this patient population. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Psoriasis, Fatty Liver
- What is being tested?
- lifestyle modification and usual lifestyle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Sep 2021to 15 Mar 2022
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- psoriasis obese patients with coexisting fatty liver
- chronic plaque psoriasis
- patients who will not show any change in immuno-modulating psoriasis therapies for at least five months before participation in the study.
Who cannot join
- no metabolic syndrome
- no renal or cardiac or pulmonary disorders
- other types of psoriasis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy Cairo University
Giza, Dokki
Ali Ismail, lecturer, 02 01005154209, allooka2012@gmail.com
About this study
Official title: Response of Fatty Liver to Lifestyle Modification in Psoriasis Patients
Several recent reports have shown an increased prevalence of nonalcoholic fatty liver disease (NAFLD) in those with psoriasis, which may reflect the increased occurrence of metabolic syndrome in this patient population.
Read the detailed description
the recruitment of 60 fatty live men with chronic disease, psoriasis, will be classified to lifestyle modification group (foe 12 weeks, this patients will take supervised energy or diet restriction program plus their usual immunosuppressive drugs ) and control group will continue their drug program only)
- Conditions
- Psoriasis, Fatty Liver
- Being tested
- lifestyle modification, usual lifestyle
- Medical subject headings
- Psoriasis, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle modificationOther
for 12 week, the patients of this group will receive their usual immuno-modulating therapy plus life style modification (energy or diet restriction in addition to daily walking, 15000 steps)
usual lifestyleOther
the patients will receive the usual immuno-modulating therapy with continued usual diet and activities
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | The patients of this group will receive their usual immuno-modulating therapy plus life style modification (energy or diet restriction in addition to daily walking, 15000 steps) Receives: Other: lifestyle modification |
| control group | Active comparator | The participants of this group will receive their usual immuno-modulating therapy and continuing their usual diet and activities Receives: Other: usual lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psoriasis Area and Severity Index
it is an index used to measure level and severity of psoriasis
Measured: It will be measured after 12 weeks
Secondary outcomes (6)
Dermatology Life Quality Index
it is a questinnaire used to assess life quality in psoriasis humans
Measured: It will be measured after 12 weeks
triglycerides
will measured in plasma
Measured: It will be measured after 12 weeks
AST
it is plasma aspartate transaminase
Measured: It will be measured after 12 weeks
ALT
it is plasma Alanine transaminase
Measured: It will be measured after 12 weeks
BMI
it is body mass index
Measured: It will be measured after 12 weeks
waist circumference
it will be measured at the level of umbilicus
Measured: It will be measured after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start13 Sep 2021
- Primary completion15 Mar 2022 (estimated)
- Study completion15 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125757
- Sponsor's protocol ID
- P.T.REC/012/003344
- Status last verified
- Nov 2021
- First submitted
- 17 Oct 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of Fatty Liver to Lifestyle Modification in Psoriasis Patients
- ClinicalTrials.gov ID
- NCT05125757
- Acronym / sponsor ID
- P.T.REC/012/003344
- Conditions
- Psoriasis, Fatty Liver
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 15 Mar 2022 (estimated)
- Study completion
- 15 Mar 2022 (estimated)
- First posted
- 18 Nov 2021 (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.
Several recent reports have shown an increased prevalence of nonalcoholic fatty liver disease (NAFLD) in those with psoriasis, which may reflect the increased occurrence of metabolic syndrome in this patient population.
Detailed description
the recruitment of 60 fatty live men with chronic disease, psoriasis, will be classified to lifestyle modification group (foe 12 weeks, this patients will take supervised energy or diet restriction program plus their usual immunosuppressive drugs ) and control group will continue their drug program only)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Other: lifestyle modificationThe patients of this group will receive their usual immuno-modulating therapy plus life style modification (energy or diet restriction in addition to daily walking, 15000 steps) |
| control group | Active comparator | Other: usual lifestyleThe participants of this group will receive their usual immuno-modulating therapy and continuing their usual diet and activities |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- psoriasis obese patients with coexisting fatty liver
- chronic plaque psoriasis
- patients who will not show any change in immuno-modulating psoriasis therapies for at least five months before participation in the study.
Key exclusion criteria (3 listed)
- no metabolic syndrome
- no renal or cardiac or pulmonary disorders
- other types of psoriasis
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 |
|---|---|---|
| lifestyle modificationfor 12 week, the patients of this group will receive their usual immuno-modulating therapy plus life style modification (energy or diet restriction in addition to daily walking, 15000 steps) | Other | intervention group |
| usual lifestylethe patients will receive the usual immuno-modulating therapy with continued usual diet and activities | Other | control group |
Primary outcome
Psoriasis Area and Severity Index
Time frame: It will be measured after 12 weeks
it is an index used to measure level and severity of psoriasis
6 secondary outcomes
Dermatology Life Quality Index
Time frame: It will be measured after 12 weeks
triglycerides
Time frame: It will be measured after 12 weeks
AST
Time frame: It will be measured after 12 weeks
ALT
Time frame: It will be measured after 12 weeks
BMI
Time frame: It will be measured after 12 weeks
waist circumference
Time frame: It will be measured after 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
Related trials for Psoriasis
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
Plaque Psoriasis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
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.
Ali Ismail, lecturer 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 lifestyle modification and usual lifestyle in people with Psoriasis and Fatty Liver, 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Ismail, lecturer (02 01005154209, allooka2012@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psoriasis Area and Severity Index (time frame: It will be measured after 12 weeks). 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 18 Nov 2021.