Back to resultsLifestyle Modification in Psoriatic Patients With Fatty Liver
Primary Purpose
Psoriasis, Fatty Liver
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lifestyle modification
usual lifestyle
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- no metabolic syndrome
- no renal or cardiac or pulmonary disorders
- other types of psoriasis
Sites / Locations
- Faculty of Physical Therapy Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
intervention group
control group
Arm Description
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 participants of this group will receive their usual immuno-modulating therapy and continuing their usual diet and activities
Outcomes
Primary Outcome Measures
Psoriasis Area and Severity Index
it is an index used to measure level and severity of psoriasis
Secondary Outcome Measures
Dermatology Life Quality Index
it is a questinnaire used to assess life quality in psoriasis humans
triglycerides
will measured in plasma
AST
it is plasma aspartate transaminase
ALT
it is plasma Alanine transaminase
BMI
it is body mass index
waist circumference
it will be measured at the level of umbilicus
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05125757
Brief Title
Lifestyle Modification in Psoriatic Patients With Fatty Liver
Official Title
Response of Fatty Liver to Lifestyle Modification in Psoriasis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Anticipated)
Study Completion Date
March 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Fatty Liver
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
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)
Arm Title
control group
Arm Type
Active Comparator
Arm Description
The participants of this group will receive their usual immuno-modulating therapy and continuing their usual diet and activities
Intervention Type
Other
Intervention Name(s)
lifestyle modification
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
usual lifestyle
Intervention Description
the patients will receive the usual immuno-modulating therapy with continued usual diet and activities
Primary Outcome Measure Information:
Title
Psoriasis Area and Severity Index
Description
it is an index used to measure level and severity of psoriasis
Time Frame
It will be measured after 12 weeks
Secondary Outcome Measure Information:
Title
Dermatology Life Quality Index
Description
it is a questinnaire used to assess life quality in psoriasis humans
Time Frame
It will be measured after 12 weeks
Title
triglycerides
Description
will measured in plasma
Time Frame
It will be measured after 12 weeks
Title
AST
Description
it is plasma aspartate transaminase
Time Frame
It will be measured after 12 weeks
Title
ALT
Description
it is plasma Alanine transaminase
Time Frame
It will be measured after 12 weeks
Title
BMI
Description
it is body mass index
Time Frame
It will be measured after 12 weeks
Title
waist circumference
Description
it will be measured at the level of umbilicus
Time Frame
It will be measured after 12 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
self-representation of gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
no metabolic syndrome
no renal or cardiac or pulmonary disorders
other types of psoriasis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Therapy Cairo University
City
Giza
State/Province
Dokki
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
allooka2012@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Lifestyle Modification in Psoriatic Patients With Fatty Liver
We'll reach out to this number within 24 hrs