ClinicalTrials.gg
Status unknownNCT05632042Updated Nov 30, 2022

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

An interventional study of lifestyle modification (exercise and control of diet) in Psoriasis, Metabolic Syndrome and Erectile Dysfunction, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to male participants aged 35 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-11-30.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
35 Years to 45 Years
Sex
Male
01

Study summary

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.

02

Conditions studied

  • Psoriasis
  • Metabolic Syndrome
  • Erectile Dysfunction
03

In context

Psoriasis

1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 1,472 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 45 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • psoriatic married men with metabolic syndrome and erectile dysfunction

Exclusion criteria

Exclusion Criteria:

  • patients with heart, respiratory, other autoimmune problems
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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)

  • 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.

Interventions

  • Behaviorallifestyle 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)

06

What researchers measure

Primary outcomes

  1. International Index of Erectile Function

    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 outcomes

  1. psoriasis area and severity index

    it is a tool used to measure the severity and extent of psoriasis.

    Time frame: It will be measured after 12-week intervention

  2. body mass index

    patients will be assessed with empty bowel and bladder

    Time frame: It will be measured after 12-week intervention

  3. systolic blood pressure

    it will be measured using sphygmomanometer

    Time frame: It will be measured after 12-week intervention

  4. diastolic blood presure

    it will be measured using sphygmomanometer

    Time frame: It will be measured after 12-week intervention

  5. waist circumference

    it will be measured by in elastic tape

    Time frame: It will be measured after 12-week intervention

  6. blood glucose

    it will be measured in fasting status

    Time frame: It will be measured after 12-week intervention

  7. triglycerides

    it will be measured in serum

    Time frame: It will be measured after 12-week intervention

  8. high density lipoprotein

    it will be measured in serum

    Time frame: It will be measured after 12-week intervention

07

Study locations

1 of 1 sites recruiting
  • Cairo Unoversity
    Giza, Egypt
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2022 (actual). Primary completion is estimated for Apr 2023, 6 months after the start.

Of 118 non-industry interventional studies with no phase under Psoriasis, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 41. This study's planned 6 months is below that.

Counting every sponsor, half of 136 studies reached it within 18 months; a quarter within 8 and three quarters within 37.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2022
First posted
Nov 30, 2022
StartActual
Oct 16, 2022
Primary completionEst.
Apr 16, 2023
CompletionEst.
Apr 16, 2023
Last update
Nov 30, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05632042
Lead sponsor
Cairo University
Responsible party
Ali Mohamed Ali ismail (lecturer of Physical Therapy for Cardiovascular / Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University, Cairo University) — Principal investigator
First posted
Nov 30, 2022
Start date
Oct 16, 2022
Primary completion
Apr 16, 2023 (estimated)
Completion
Apr 16, 2023 (estimated)
Last update
Nov 30, 2022

Study contacts

Ali Ismail, lecturer
Contact
ali.mohamed@pt.cu.edu.eg
02 01005154209
Ali Ismail, lecturer
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion