Lifestyle Modification in Psoriatic Patients With Fatty Liver
Response of Fatty Liver to Lifestyle Modification in Psoriasis Patients
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 13, 2021
CompletedFirst Submitted
Initial submission to the registry
October 17, 2021
CompletedFirst Posted
Study publicly available on registry
November 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2022
CompletedNovember 18, 2021
November 1, 2021
6 months
October 17, 2021
November 7, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Psoriasis Area and Severity Index
it is an index used to measure level and severity of psoriasis
It will be measured after 12 weeks
Secondary Outcomes (6)
Dermatology Life Quality Index
It will be measured after 12 weeks
triglycerides
It will be measured after 12 weeks
AST
It will be measured after 12 weeks
ALT
It will be measured after 12 weeks
BMI
It will be measured after 12 weeks
- +1 more secondary outcomes
Study Arms (2)
intervention group
EXPERIMENTALThe 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 COMPARATORThe participants of this group will receive their usual immuno-modulating therapy and continuing their usual diet and activities
Interventions
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)
the patients will receive the usual immuno-modulating therapy with continued usual diet and activities
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- no metabolic syndrome
- no renal or cardiac or pulmonary disorders
- other types of psoriasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Physical Therapy Cairo University
Giza, Dokki, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ali Ismail, lecturer
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University
Study Record Dates
First Submitted
October 17, 2021
First Posted
November 18, 2021
Study Start
September 13, 2021
Primary Completion
March 15, 2022
Study Completion
March 15, 2022
Last Updated
November 18, 2021
Record last verified: 2021-11