Polycystic Ovary SyndromeNCT07708766
Effect of High Intensity Interval Training on Insulin Resistance in Polycystic Ovarian Syndrome
A study testing Intermittent fasting diet group and High intensity interval training in people with Polycystic Ovary Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted to investigate the effect of high- intensity interval training on insulin resistance in polycystic ovarian syndrome. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Intermittent fasting diet group and High intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2026to 25 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Obese women with polycystic Ovarian Syndrome (PCOS) as clinically diagnosed by the gynecologist.
- Their ages will be ranged from 20 to 35 years old.
- Their body mass index will be ranged from 30-40 kg/m2.
- Their waist/hip ratio will be > 0.8.
- All of them should have at least two criteria of the Rotterdam diagnostic criteria of PCOS.
Who cannot join
- Cushing syndrome, diabetes mellitus.
- Thyroid dysfunction.
- Hypothalamic amenorrhea, ovarian hyperplasia.
- Respiratory, renal and liver dysfunction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study will be conducted to investigate the effect of high- intensity interval training on insulin resistance in polycystic ovarian syndrome.
Read the detailed description
Women with polycystic ovarian syndrome (PCOS) are at increased risk for glucose intolerance, dyslipidemia, subfertility, obstetric complications and psychosexual disorders.
The prevalence of insulin resistance in PCOS can range from 44% to 70%. Studies have indicated that worsening of insulin resistance over time in obese women with PCOS is associated with early development of diabetes mellitus type 2.
Interventions like oral contraceptive pills give the higher risk of endometrial cancer for women with PCOS. However, lifestyle correction appears to be the sustainable therapy of PCOS.
High-intensity interval training (HIIT) consists of short periods of intense exercise (80% of maximal heart rate) alternated with periods of active recovery or rest. It is a relatively time-efficient training strategy to improve metabolic health and has been considered more enjoyable than moderate-to-vigorous intensity continuous training HIIT increases skeletal muscle oxidative capacity and appears to be effective in improving insulin sensitivity, particularly in those at increased risk type 2 diabetes mellitus.
Intermittent fasting had a powerful effect on improvement of glucose metabolism by lowering insulin resistance, improvement of systemic inflammatory diseases and even expansion of life span.
So, this study will be conducted to provide new evidences and information about the efficacy of high intensity interval training on insulin resistance in women suffering from PCOS, to manage this problem upon them and add new information to the field of physical therapy.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Intermittent fasting diet group, High intensity interval training
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent fasting diet groupOther
Fasting for 14 hours and eating window for 10 hours (1400 kcal) as prescribed by nutrition specialist. Intermittent fasting is an approach of eating that focuses on when you eat rather than on what you eat.
- During fasting hours (fasting window) the participants are allowed to drink water, tea, coffee and drinks without sugar.
- During eating hours (eating window) the participants will follow 1400 kcal diet.
- The diet targets recommended with respect to high intake of vegetables (3-4 serve daily), fruits (1-2 serve daily), fish, lean meats and poultry (3-4 serve daily), fat free and low fat dairy products (2-3 serve daily), and legumes, nuts and seeds (4-5 serves per week), carbohydrates (3-4 serve daily).
High intensity interval trainingOther
All participants will receive High intensity interval training program in the form of walking on the electronic treadmill for 40 min through 3 phases: Warm-up phase: included walking on the treadmill with light intensity (50% of maximal heart rate (MHR)) for 10 min, Actual phase: included walking on the treadmill with high intensity intervals (80-85% of MHR) repeated for 4 times, with 3-min active recovery at (70% of MHR) between intervals then Cool-downs phase: included walking on the treadmill with light intensity (50% of MHR) for 5 min for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent fasting diet group | Active comparator | The participants will follow intermittent fasting diet only for 12 weeks Receives: Other: Intermittent fasting diet group |
| High Intensity Interval Training and intermittent fasting diet group | Experimental | The participants will receive High Intensity Interval Training program for 40 min, 3 sessions per week, in addition to intermittent fasting diet for 12 weeks, Receives: Other: Intermittent fasting diet group; Other: High intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Body weight will be measured by using weight and height scale before and after treatment program.
Measured: 12 weeks
Body mass index
It will be calculated by dividing weight in kilograms divided by height meter square.
Measured: 12 weeks
Waist circumference
The waist circumference will be measured by tape measure from the narrowest point between the lower border of the ribcage and the iliac crest at the end of normal expiration.
Measured: 12 weeks
Hip circumference
Hip circumference will be measured at the widest part of the hip using the tape measurement.
Measured: 12 weeks
Waist/ hip ratio
Waist /hip ratio will be calculated by dividing waist circumference by hip circumference.
Measured: 12 weeks
Oral glucose tolerance test
Venous blood sample will be collected from each participant to determine level of oral glucose tolerance test.
The 2-hour plasma glucose level <140 mg/dL (7.8 MMOL/L) is considered normal. A blood glucose level between 140 and 199 mg/dL (7.8 and 11 MMOL/L) is considered impaired glucose tolerance, or pre- diabetes.
Measured: 12 weeks
Fasting plasma insulin
Venous blood sample will be collected from each participant to determine level of fasting plasma insulin level at least 8 hours of fasting. Normal insulin level is 3-8µIU/ml, mild insulin resistance is 8-10µIU/ml, moderate insulin resistance is 10-12µIU/ml and severe insulin resistance is >12 µIU/ml.
Measured: 12 weeks
Glucose /insulin ratio
A glucose /insulin ratio of less than 4.5 has been shown to be sensitive and specific for insulin resistance in a group of women with polycystic Ovarian Syndrome.
Measured: 12 weeks
Homeostasis Model Assessment (HOMA IR)
Venous blood sample will be collected from each participant to determine level of homeostasis Model Assessment (HOMA IR). It will be calculated for all participants before and after the end of the treatment according to the following equation: HOMA.IR = insulin (MU/L) × glucose (mmol/L)/22.5. HOMA_IR ≥2.5 should be considered a reasonable indicator of insulin resistance.
Measured: 12 weeks
Secondary outcomes (1)
Assessment of quality of life
Polycystic Ovary Syndrome Quality of Life scale (PCOSQ) will be used. It is composed of 26 items categorized into five sections: emotions (8 items), body hair (5 items), weight concerns (5 items), infertility concerns (4 items), and menstrual irregularities (4 items). Each item is scored with a seven-point. Like rating system where seven represents the best situation and 1 represents the worst situation. The sum of the total points in each item per domain will be evaluated. Ultimately, the first interval values (from 1 to < 3 points) represent marked effects on health related quality of life (HRQOL); second interval values (from 3 to < 4 points) represent the marginal effect on HRQOL; third interval values (from 4 to < 5 points) represent the minimal effect on HRQOL; fourth interval (5 points) represents no effect on HRQOL.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start20 Jul 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion25 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Tharwat Mohamed, Cairo University
- Investigators
- Azza Nashed, Professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708766
- Sponsor's protocol ID
- P.T.REC/012/005735
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 16 Jul 2026
- 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 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Intensity Interval Training on Insulin Resistance in Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT07708766
- Acronym / sponsor ID
- P.T.REC/012/005735
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 25 Jan 2027 (estimated)
- First posted
- 16 Jul 2026 (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.
This study will be conducted to investigate the effect of high- intensity interval training on insulin resistance in polycystic ovarian syndrome.
Detailed description
Women with polycystic ovarian syndrome (PCOS) are at increased risk for glucose intolerance, dyslipidemia, subfertility, obstetric complications and psychosexual disorders.
The prevalence of insulin resistance in PCOS can range from 44% to 70%. Studies have indicated that worsening of insulin resistance over time in obese women with PCOS is associated with early development of diabetes mellitus type 2.
Interventions like oral contraceptive pills give the higher risk of endometrial cancer for women with PCOS. However, lifestyle correction appears to be the sustainable therapy of PCOS.
High-intensity interval training (HIIT) consists of short periods of intense exercise (80% of maximal heart rate) alternated with periods of active recovery or rest. It is a relatively time-efficient training strategy to improve metabolic health and has been considered more enjoyable than moderate-to-vigorous intensity continuous training HIIT increases skeletal muscle oxidative capacity and appears to be effective in improving insulin sensitivity, particularly in those at increased risk type 2 diabetes mellitus.
Intermittent fasting had a powerful effect on improvement of glucose metabolism by lowering insulin resistance, improvement of systemic inflammatory diseases and even expansion of life span.
So, this study will be conducted to provide new evidences and information about the efficacy of high intensity interval training on insulin resistance in women suffering from PCOS, to manage this problem upon them and add new information to the field of physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent fasting diet group | Active comparator | Other: Intermittent fasting diet groupThe participants will follow intermittent fasting diet only for 12 weeks |
| High Intensity Interval Training and intermittent fasting diet group | Experimental | Other: Intermittent fasting diet group, Other: High intensity interval trainingThe participants will receive High Intensity Interval Training program for 40 min, 3 sessions per week, in addition to intermittent fasting diet for 12 weeks, |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Obese women with polycystic Ovarian Syndrome (PCOS) as clinically diagnosed by the gynecologist.
- Their ages will be ranged from 20 to 35 years old.
- Their body mass index will be ranged from 30-40 kg/m2.
- Their waist/hip ratio will be > 0.8.
- All of them should have at least two criteria of the Rotterdam diagnostic criteria of PCOS.
Key exclusion criteria (4 listed)
- Cushing syndrome, diabetes mellitus.
- Thyroid dysfunction.
- Hypothalamic amenorrhea, ovarian hyperplasia.
- Respiratory, renal and liver dysfunction.
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 |
|---|---|---|
| Intermittent fasting diet groupFasting for 14 hours and eating window for 10 hours (1400 kcal) as prescribed by nutrition specialist. Intermittent fasting is an approach of eating that focuses on when you eat rather than on what you eat. * During fasting hours (fasting window) the participants are allowed to drink water, tea, coffee and drinks without sugar. * During eating hours (eating window) the participants will follow 1400 kcal diet. * The diet targets recommended with respect to high intake of vegetables (3-4 serve daily), fruits (1-2 serve daily), fish, lean meats and poultry (3-4 serve daily), fat free and low fat dairy products (2-3 serve daily), and legumes, nuts and seeds (4-5 serves per week), carbohydrates (3-4 serve daily). | Other | High Intensity Interval Training and intermittent fasting diet group, Intermittent fasting diet group |
| High intensity interval trainingAll participants will receive High intensity interval training program in the form of walking on the electronic treadmill for 40 min through 3 phases: Warm-up phase: included walking on the treadmill with light intensity (50% of maximal heart rate (MHR)) for 10 min, Actual phase: included walking on the treadmill with high intensity intervals (80-85% of MHR) repeated for 4 times, with 3-min active recovery at (70% of MHR) between intervals then Cool-downs phase: included walking on the treadmill with light intensity (50% of MHR) for 5 min for 12 weeks. | Other | High Intensity Interval Training and intermittent fasting diet group |
Primary outcome
Body weight
Time frame: 12 weeks
Body weight will be measured by using weight and height scale before and after treatment program.
Body mass index
Time frame: 12 weeks
It will be calculated by dividing weight in kilograms divided by height meter square.
Waist circumference
Time frame: 12 weeks
The waist circumference will be measured by tape measure from the narrowest point between the lower border of the ribcage and the iliac crest at the end of normal expiration.
Hip circumference
Time frame: 12 weeks
Hip circumference will be measured at the widest part of the hip using the tape measurement.
Waist/ hip ratio
Time frame: 12 weeks
Waist /hip ratio will be calculated by dividing waist circumference by hip circumference.
Oral glucose tolerance test
Time frame: 12 weeks
Venous blood sample will be collected from each participant to determine level of oral glucose tolerance test. The 2-hour plasma glucose level <140 mg/dL (7.8 MMOL/L) is considered normal. A blood glucose level between 140 and 199 mg/dL (7.8 and 11 MMOL/L) is considered impaired glucose tolerance, or pre- diabetes.
Fasting plasma insulin
Time frame: 12 weeks
Venous blood sample will be collected from each participant to determine level of fasting plasma insulin level at least 8 hours of fasting. Normal insulin level is 3-8µIU/ml, mild insulin resistance is 8-10µIU/ml, moderate insulin resistance is 10-12µIU/ml and severe insulin resistance is >12 µIU/ml.
Glucose /insulin ratio
Time frame: 12 weeks
A glucose /insulin ratio of less than 4.5 has been shown to be sensitive and specific for insulin resistance in a group of women with polycystic Ovarian Syndrome.
Homeostasis Model Assessment (HOMA IR)
Time frame: 12 weeks
Venous blood sample will be collected from each participant to determine level of homeostasis Model Assessment (HOMA IR). It will be calculated for all participants before and after the end of the treatment according to the following equation: HOMA.IR = insulin (MU/L) × glucose (mmol/L)/22.5. HOMA_IR ≥2.5 should be considered a reasonable indicator of insulin resistance.
1 secondary outcome
Assessment of quality of life
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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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.
Azza Nashed, Professor study chair
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 testing Intermittent fasting diet group and High intensity interval training in people with Polycystic Ovary 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 16 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hagar Mohamed (01141667742, hagertharwat20172018@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 12 weeks). The study lists 9 primary outcomes in all. 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 16 Jul 2026.