An interventional study of Intermittent fasting diet group and High intensity interval training in Polycystic Ovary Syndrome, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
This study will be conducted to investigate the effect of high- intensity interval training on insulin resistance in polycystic ovarian syndrome.
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's planned enrollment of 50 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
The participants will follow intermittent fasting diet only for 12 weeks
Other: Intermittent fasting diet group
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,
Other: Intermittent fasting diet group · Other: High intensity interval training
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).
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.
Body weight
Body weight will be measured by using weight and height scale before and after treatment program.
Time frame: 12 weeks
Body mass index
It will be calculated by dividing weight in kilograms divided by height meter square.
Time frame: 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.
Time frame: 12 weeks
Hip circumference
Hip circumference will be measured at the widest part of the hip using the tape measurement.
Time frame: 12 weeks
Waist/ hip ratio
Waist /hip ratio will be calculated by dividing waist circumference by hip circumference.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 weeks
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.
Time frame: 12 weeks
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Cairo University