Response of Metabolic Syndrome and Sexual Dysfunction to Lifestyle Changes in Men With Psoriasis

November 20, 2022 updated by: Ali Mohamed Ali ismail, Cairo University

Response of Metabolic Syndrome and Sexual Dysfunction to Lifestyle Changes/Modifications in Men With Psoriasis

complaint of sexual dysfunction and metabolic syndrome are highly reported in men with psoriasis

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

erectile dysfunction (ED) psoriatic men with metabolic syndrome (number of the patients will be 60) will assigned to study group (group = 30 patients) that will receive lifestyle changes (12 weeks of low calorie diet and moderate-intensity walking on treadmill, the walking duration will be 40 minutes, the walking will be three times per week) or control group (group=30 patients) that will receive no lifestyle changes/modifications.

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 Contact

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Cairo Unoversity

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

31 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • psoriatic married men with metabolic syndrome and erectile dysfunction

Exclusion Criteria:

  • patients with heart, respiratory, other autoimmune problems

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: lifestyle-modification group
erectile dysfunction (ED) psoriatic men with metabolic syndrome (group = 30 patients) will receive lifestyle changes (12 weeks of low calorie diet and moderate-intensity walking on treadmill, the walking duration will be 40 minutes, the walking will be three times per week)
Behavioral: lifestyle modification (exercise and control of diet)
erectile dysfunction (ED) psoriatic men with metabolic syndrome that will receive lifestyle changes (12 weeks of low calorie diet and moderate-intensity walking on treadmill, the walking duration will be 40 minutes, the walking will be three times per week)
No Intervention: control group
erectile dysfunction (ED) psoriatic men with metabolic syndrome (number of the patients will be 30) that will receive no lifestyle changes/modifications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Index of Erectile Function
Time Frame: It will be measured after 12-week intervention
Arabic version of this 5-item questionnaire will used to assess erectile function/dysfunction
It will be measured after 12-week intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
psoriasis area and severity index
Time Frame: It will be measured after 12-week intervention
it is a tool used to measure the severity and extent of psoriasis.
It will be measured after 12-week intervention
body mass index
Time Frame: It will be measured after 12-week intervention
patients will be assessed with empty bowel and bladder
It will be measured after 12-week intervention
systolic blood pressure
Time Frame: It will be measured after 12-week intervention
it will be measured using sphygmomanometer
It will be measured after 12-week intervention
diastolic blood presure
Time Frame: It will be measured after 12-week intervention
it will be measured using sphygmomanometer
It will be measured after 12-week intervention
waist circumference
Time Frame: It will be measured after 12-week intervention
it will be measured by in elastic tape
It will be measured after 12-week intervention
blood glucose
Time Frame: It will be measured after 12-week intervention
it will be measured in fasting status
It will be measured after 12-week intervention
triglycerides
Time Frame: It will be measured after 12-week intervention
it will be measured in serum
It will be measured after 12-week intervention
high density lipoprotein
Time Frame: It will be measured after 12-week intervention
it will be measured in serum
It will be measured after 12-week intervention

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)

October 16, 2022

Primary Completion (Anticipated)

April 16, 2023

Study Completion (Anticipated)

April 16, 2023

Study Registration Dates

First Submitted

November 20, 2022

First Submitted That Met QC Criteria

November 20, 2022

First Posted (Actual)

November 30, 2022

Study Record Updates

Last Update Posted (Actual)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 20, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004117

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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