Lifestyle Modification in Psoriatic Patients With Fatty Liver

Psoriasis Clinical Trial

Official title:

Response of Fatty Liver to Lifestyle Modification in Psoriasis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05125757
• Other study ID #: P.T.REC/012/003344
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2021
• Est. completion date: March 15, 2022

Study information

• Verified date: November 2021
• Source: Cairo University
• Contact: Ali Ismail, lecturer
• Phone: 02 01005154209
• Email: allooka2012[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Psoriasis

Intervention

Other:
• lifestyle modification
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 lifestyle
the patients will receive the usual immuno-modulating therapy with continued usual diet and activities

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy Cairo University	Giza	Dokki

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Dermatology Life Quality Index	it is a questinnaire used to assess life quality in psoriasis humans	It will be measured after 12 weeks
Secondary	triglycerides	will measured in plasma	It will be measured after 12 weeks
Secondary	AST	it is plasma aspartate transaminase	It will be measured after 12 weeks
Secondary	ALT	it is plasma Alanine transaminase	It will be measured after 12 weeks
Secondary	BMI	it is body mass index	It will be measured after 12 weeks
Secondary	waist circumference	it will be measured at the level of umbilicus	It will be measured after 12 weeks