Lifestyle Modification in Psoriatic Patients With Fatty Liver

NCT ID: NCT05125757

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-13

Study Completion Date

2022-03-15

Brief Summary

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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

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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

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Psoriasis Fatty Liver

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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)

Group Type EXPERIMENTAL

lifestyle modification

Intervention Type OTHER

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)

control group

The participants of this group will receive their usual immuno-modulating therapy and continuing their usual diet and activities

Group Type ACTIVE_COMPARATOR

usual lifestyle

Intervention Type OTHER

the patients will receive the usual immuno-modulating therapy with continued usual diet and activities

Interventions

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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)

Intervention Type OTHER

usual lifestyle

the patients will receive the usual immuno-modulating therapy with continued usual diet and activities

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ali Mohamed Ali ismail

lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Ismail, lecturer

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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Faculty of Physical Therapy Cairo University

Giza, Dokki, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ali Ismail, lecturer

Role: CONTACT

Phone: 02 01005154209

Email: [email protected]

Facility Contacts

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Ali Ismail, lecturer

Role: primary

Other Identifiers

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P.T.REC/012/003344

Identifier Type: -

Identifier Source: org_study_id