PsoriasisNCT05632042
Response of Metabolic Syndrome and Sexual Dysfunction to Lifestyle Changes in Men With Psoriasis
A study of Psoriasis and Metabolic Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
complaint of sexual dysfunction and metabolic syndrome are highly reported in men with psoriasis Read more about this study
- Who is it for?
- Ages 35 to 45 years, men only
- Conditions the study is for
- Psoriasis, Metabolic Syndrome, Erectile Dysfunction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Oct 2022to 16 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- psoriatic married men with metabolic syndrome and erectile dysfunction
Who cannot join
- patients with heart, respiratory, other autoimmune problems
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo Unoversity
Giza
Ali Ismail, lecturer, 01005154209, allooka2012@gmail.com
About this study
Official title: 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
Read the 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.
- Conditions
- Psoriasis, Metabolic Syndrome, Erectile Dysfunction
- Being tested
- lifestyle modification (exercise and control of diet)
- Medical subject headings
- Psoriasis, Metabolic Syndrome, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle modification (exercise and control of diet)Behavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| lifestyle-modification group | Experimental | 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) Receives: Behavioral: lifestyle modification (exercise and control of diet) |
| control group | No intervention | erectile dysfunction (ED) psoriatic men with metabolic syndrome (number of the patients will be 30) that will receive no lifestyle changes/modifications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Index of Erectile Function
Arabic version of this 5-item questionnaire will used to assess erectile function/dysfunction
Measured: It will be measured after 12-week intervention
Secondary outcomes (8)
psoriasis area and severity index
it is a tool used to measure the severity and extent of psoriasis.
Measured: It will be measured after 12-week intervention
body mass index
patients will be assessed with empty bowel and bladder
Measured: It will be measured after 12-week intervention
systolic blood pressure
it will be measured using sphygmomanometer
Measured: It will be measured after 12-week intervention
diastolic blood presure
it will be measured using sphygmomanometer
Measured: It will be measured after 12-week intervention
waist circumference
it will be measured by in elastic tape
Measured: It will be measured after 12-week intervention
blood glucose
it will be measured in fasting status
Measured: It will be measured after 12-week intervention
triglycerides
it will be measured in serum
Measured: It will be measured after 12-week intervention
high density lipoprotein
it will be measured in serum
Measured: It will be measured after 12-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start16 Oct 2022
- Primary completion16 Apr 2023 (estimated)
- Study completion16 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Mohamed Ali ismail, Cairo University
- Investigators
- Ali Ismail, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632042
- Sponsor's protocol ID
- P.T.REC/012/004117
- Status last verified
- Nov 2022
- First submitted
- 20 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response of Metabolic Syndrome and Sexual Dysfunction to Lifestyle Changes/Modifications in Men With Psoriasis
- ClinicalTrials.gov ID
- NCT05632042
- Acronym / sponsor ID
- P.T.REC/012/004117
- Conditions
- Psoriasis, Metabolic Syndrome, Erectile Dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Oct 2022 (actual)
- Primary completion
- 16 Apr 2023 (estimated)
- Study completion
- 16 Apr 2023 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lifestyle-modification group | Experimental | Behavioral: lifestyle modification (exercise and control of diet)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) |
| control group | No intervention | –erectile dysfunction (ED) psoriatic men with metabolic syndrome (number of the patients will be 30) that will receive no lifestyle changes/modifications. |
Who may qualify
- Ages
- 35 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- psoriatic married men with metabolic syndrome and erectile dysfunction
Key exclusion criteria (1 listed)
- patients with heart, respiratory, other autoimmune problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | lifestyle-modification group |
Primary outcome
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
8 secondary outcomes
psoriasis area and severity index
Time frame: It will be measured after 12-week intervention
body mass index
Time frame: It will be measured after 12-week intervention
systolic blood pressure
Time frame: It will be measured after 12-week intervention
diastolic blood presure
Time frame: It will be measured after 12-week intervention
waist circumference
Time frame: It will be measured after 12-week intervention
blood glucose
Time frame: It will be measured after 12-week intervention
triglycerides
Time frame: It will be measured after 12-week intervention
high density lipoprotein
Time frame: It will be measured after 12-week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Ismail, lecturer principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Psoriasis and Metabolic Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ali Ismail, lecturer (02 01005154209, ali.mohamed@pt.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Index of Erectile Function (time frame: It will be measured after 12-week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2022.