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

Primary Purpose

Psoriasis, Metabolic Syndrome, Erectile Dysfunction

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lifestyle modification (exercise and control of diet)
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

35 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: psoriatic married men with metabolic syndrome and erectile dysfunction Exclusion Criteria: patients with heart, respiratory, other autoimmune problems

Sites / Locations

  • Cairo UnoversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

lifestyle-modification group

control group

Arm Description

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)

erectile dysfunction (ED) psoriatic men with metabolic syndrome (number of the patients will be 30) that will receive no lifestyle changes/modifications.

Outcomes

Primary Outcome Measures

International Index of Erectile Function
Arabic version of this 5-item questionnaire will used to assess erectile function/dysfunction

Secondary Outcome Measures

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

Full Information

First Posted
November 20, 2022
Last Updated
November 20, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05632042
Brief Title
Response of Metabolic Syndrome and Sexual Dysfunction to Lifestyle Changes in Men With Psoriasis
Official Title
Response of Metabolic Syndrome and Sexual Dysfunction to Lifestyle Changes/Modifications in Men With Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 16, 2022 (Actual)
Primary Completion Date
April 16, 2023 (Anticipated)
Study Completion Date
April 16, 2023 (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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis, Metabolic Syndrome, Erectile Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
lifestyle-modification group
Arm Type
Experimental
Arm Description
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)
Arm Title
control group
Arm Type
No Intervention
Arm Description
erectile dysfunction (ED) psoriatic men with metabolic syndrome (number of the patients will be 30) that will receive no lifestyle changes/modifications.
Intervention Type
Behavioral
Intervention Name(s)
lifestyle modification (exercise and control of diet)
Intervention Description
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)
Primary Outcome Measure Information:
Title
International Index of Erectile Function
Description
Arabic version of this 5-item questionnaire will used to assess erectile function/dysfunction
Time Frame
It will be measured after 12-week intervention
Secondary Outcome Measure Information:
Title
psoriasis area and severity index
Description
it is a tool used to measure the severity and extent of psoriasis.
Time Frame
It will be measured after 12-week intervention
Title
body mass index
Description
patients will be assessed with empty bowel and bladder
Time Frame
It will be measured after 12-week intervention
Title
systolic blood pressure
Description
it will be measured using sphygmomanometer
Time Frame
It will be measured after 12-week intervention
Title
diastolic blood presure
Description
it will be measured using sphygmomanometer
Time Frame
It will be measured after 12-week intervention
Title
waist circumference
Description
it will be measured by in elastic tape
Time Frame
It will be measured after 12-week intervention
Title
blood glucose
Description
it will be measured in fasting status
Time Frame
It will be measured after 12-week intervention
Title
triglycerides
Description
it will be measured in serum
Time Frame
It will be measured after 12-week intervention
Title
high density lipoprotein
Description
it will be measured in serum
Time Frame
It will be measured after 12-week intervention

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
based on self-representation of gender identity
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: psoriatic married men with metabolic syndrome and erectile dysfunction Exclusion Criteria: patients with heart, respiratory, other autoimmune problems
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ali Ismail, lecturer
Phone
02 01005154209
Email
ali.mohamed@pt.cu.edu.eg
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
Cairo Unoversity
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ali Ismail, lecturer
Phone
01005154209
Email
allooka2012@gmail.com

12. IPD Sharing Statement

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

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