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NCT Number: NCT06893913

Effect of Addition of Pyramidal Exercise to Intermittent Fasting on Dryness of Eye in Pre-diabetic Psoriasis Patients

insulin resistant psoriatic obese patients may complain problems of dryness of eye. Intermittent fasting may improve dryness of eye, obesity, insulin resistance, and psoriasis. Exercise, as applied in pyramidal form, if added to intermittent fasting may improve effect of intermittent fasting.

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Key information

About this study

forty obese patients with dryness of eye, obesity, insulin resistance (prediabetes), and psoriasis (chronic plaque) will randomly distributed to group I (n =20 patients) or group II (n=20). Both groups will receive The intermittent fasting regimen consisted of eating ad libitum for five days and then will restrict calories ('fasting') for two days per week, for a duration of 12 weeks. On the fasting days, participants will be instructed to restrict their calories to a maximum of 600 kcal/day for females and 650 kcal/day for males.

The intermittent fasting intervention will consist of a dietary intervention based on the 5:2 fasting diet. Subjects will be asked to consume a total of allowed calories in a window of 6 hours or less from 8:00 am till 2:00 pm, twice per week on 2 non-consecutive days.

Group I will receive a pyramidal training will be adopted for nearly 60 minutes (nearly two rounds of 21 minutes of running on electronic treadmill will be separated with 10 minutes of rest between the two rounds. Also, warming (4 minutes before start of pyrimidal trianing) and cooling (4 minutes after pyramidal training) will be done through gentle stretching exercises/activities. the exercise will be applied 3 times weekly for 2 weeks

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • chronic plaque psoriasis
  • obesity class I
  • prediabetic persons
  • dryness of both eyes

Exclusion criteria

  • cardiac insults
  • respiratory insults
  • diabetics hypertensives or renal, hepatic insults

Treatment and study plan

pyramidal training plus intermittent fasting

Behavioral

twenty obese patients with dryness of eye, obesity, (prediabetes), and psoriasis will receive intermittent fasting consisted of eating ad libitum for 5 days and then will restrict calories ('fasting') for two days weekly, for 12 weeks. On the fasting days, participants will restrict calories to a maximum of 600 kcal/day for females and 650 kcal/day for males.

The dietary intervention will be based on the 5:2 fasting diet. Subjects will be asked to consume a total of allowed calories in a window of 6 hours or less from 8:00 am till 2:00 pm, twice per week on 2 non-consecutive days.

also this group will receive a pyramidal training nearly 60 minutes (nearly two rounds of 21 minutes of running on treadmill will be separated with 10 min of rest between the two rounds. Also, warming (4 min before start of pyrimidal trianing) and cooling (4 minu after pyramidal training) will be done through gentle stretching. the exercise will be applied 3 times weekly for 12 weeks

Intermittent fasting

Behavioral

twenty obese patients with dryness of eye, obesity, (prediabetes), and psoriasis will receive intermittent fasting consisted of eating ad libitum for 5 days and then will restrict calories ('fasting') for two days weekly, for 12 weeks. On the fasting days, participants will restrict calories to a maximum of 600 kcal/day for females and 650 kcal/day for males.

The dietary intervention will be based on the 5:2 fasting diet. Subjects will be asked to consume a total of allowed calories in a window of 6 hours or less from 8:00 am till 2:00 pm, twice per week on 2 non-consecutive days.

Primary outcomes

  1. schrimer test

    Time frame: it will be assessed after 12 weeks

    it is a test for eye dryness

Secondary outcomes

  1. Tear film break-up timing

    Time frame: it will be assessed after 12 weeks

    it is a test for eye dryness

  2. System of Dry eye scoring

    Time frame: it will be assessed after 12 weeks

    it is a questionnaire for eye dryness assessment

  3. Ocular surface disability index

    Time frame: it will be assessed after 12 weeks

    it is a questionnaire for eye dryness assessment

  4. Dermatology life quality index

    Time frame: it will be assessed after 12 weeks

    it is a questionnaire for psoriasis-associated life quality assessment

  5. Psoriasis area and severity index

    Time frame: it will be assessed after 12 weeks

    A PASI score is a tool used to measure the severity and extent of psoriasis. PASI is an acronym for Psoriasis Area and Severity Index.The PASI is a widely used instrument in psoriasis trials that assesses and grades the severity of psoriatic lesions. PASI combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease).

  6. Fasting serum blood glucose

    Time frame: it will be assessed after 12 weeks

    it will measure of blood fasting glucose

  7. Waist circumference

    Time frame: it will be assessed after 12 weeks

    it will be assessed via tape

  8. Body mass index

    Time frame: it will be assessed after 12 weeks

    it will be assessed on empty stomach

Study contacts

Contact information is provided by the study sponsor or research team.

Ali MA Isamil, Lecturer

CONTACT

[email protected]

0201005154209

hatem abdelfatah, Lecturer

CONTACT

[email protected]

02 01221594794

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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