Lifestyle Modification in Psoriatic Patients With Fatty Liver

November 7, 2021 updated by: Ali Mohamed Ali ismail, Cairo University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dokki
      • Giza, Dokki, Egypt
        • Recruiting
        • Faculty of Physical Therapy Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
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: 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)
Active Comparator: control group
The participants of this group will receive their usual immuno-modulating therapy and continuing their usual diet and activities
Other: usual lifestyle
the patients will receive the usual immuno-modulating therapy with continued usual diet and activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
It will be measured after 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2021

Primary Completion (Anticipated)

March 15, 2022

Study Completion (Anticipated)

March 15, 2022

Study Registration Dates

First Submitted

October 17, 2021

First Submitted That Met QC Criteria

November 7, 2021

First Posted (Actual)

November 18, 2021

Study Record Updates

Last Update Posted (Actual)

November 18, 2021

Last Update Submitted That Met QC Criteria

November 7, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/003344

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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