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Completed

NCT Number: NCT06882291

Intermittent Fasting Diet Versus Resistive Exercise Program on Insulin Resistance in Obese Women With P.C.O.S

This study will be carried out in an attempt to know which is more effective, Intermittent fasting diet or resistive exercise program on insulin resistance in obese woman with polycystic ovarian syndrome.

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Key information

Age range

25 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mashtoul Elsouq general Hospital

‘Ezbet el-Sharika el-Miṣrîya, Egypt

About this study

Polycystic ovarian syndrome (PCOS) significantly impacts women, since the broad spectrum of clinical manifestations associated with it are significant and include reproductive dysfunction, menstrual irregularities, and an increased risk of infertility. However, the consequences of PCOS go beyond the reproductive axis, with psychological and social impairments, including stress, depression, anxiety and sexual dissatisfaction. There is also a high prevalence of dyslipidemia, hyperinsulinemia, obesity, hypertension, and glucose intolerance which are risk factors that predispose women to cardiovascular disease (CVD) and diabetes mellitus type 2 (DM2).

Improving Insulin resistance and excess adiposity are therefore key targets in PCOS management. International Evidence Based Guideline for the Assessment and Management of PCOS , highlights lifestyle intervention as the primary early management strategy. Lifestyle interventions are traditionally defined as those designed to improve dietary intake or physical activity through appropriate behavioural support. Time restricted eating (TRF), where patients are asked to consume all energy within a restricted daily time period, appears to offer more sustainable weight loss and cardiometabolic changes and may be more acceptable as a permanent lifestyle change.

Eight hour TRF may have beneficial effects on improving menstruation, hyperandrogenemia and reducing weight especially body fat, decreasing insulin resistance and chronic inflammation in women with anovulatory PCOS. TRF may be suitable for PCOS women with appropriate counseling and patient management.

The progressive resistance training (PRT) improved hyperandrogenism and the menstrual cycle as well as the functional capacity with increased muscle strength and resulted in changes in body composition with increased lean muscle mass and decreased central obesity without a reduced total weight. There were also improvements in quality of life and sexual function as complementary benefits.

So, This study will be carried out in an attempt to know Which is more effective, Intermittent fasting diet or resistive exercise program on insulin resistance in obese woman with polycystic ovarian syndrome.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Seventy two obese women diagnosed with Polycystic ovarian syndrome by the gynecologist (based on the Rotterdam diagnostic criteria)
  • Their age will range from 25 to 40 years old.
  • Overweight or obese (BMI >25 kg/m2 and < 30 kg/m2).

Exclusion criteria

  • The presence of diseases (such as congenital adrenal hyperplasia, Cushing syndrome, androgen secreting tumors, hyperprolactinemia, diabetes, thyroid diseases, Severe serious cardiovascular, gastrointestinal, kidney and liver diseases. premature ovarian failure, hypothalamic/pituitary disease
  • Hormonal contraceptive use.
  • Participants who did not complete the study were excluded from the analysis.
  • Use of medication therapy that impacts carbohydrate or lipid metabolism (oral contraceptive pills, insulin sensitizers, anti epileptics, anti psychotics, statins, and fish oil) in the recent 6 months;
  • Body weight fluctuations for more than 5% in the past 3 months; in preparation for pregnancy.
  • Perimenopausal; night shift workers; fasting for more than 16 h per day; hypotension
  • Alcohol intake for more than 100 g per week; smoking within the past 3 months
  • Engaging in high intensity exercise.

Treatment and study plan

Intermittent Fasting Diet

Other

Women in the first experimental group will follow an intermittent fasting diet, where they eat for 8 hours and fast for 16. They can skip breakfast or have an early dinner. Meals will include 500-800 calories of high-fiber and protein-rich foods. Participants can start with 2-3 fasts per week and increase gradually. They must drink 2-3L of water daily and can consume zero-calorie beverages. Weekly assessments will track progress.

Resistive exercise program

Other

Women in the second experimental group will receive medical treatment and follow an 8-week resistive exercise program (30 min, 5 days/week). Exercises target the upper body, abdomen, and lower limbs, starting with a 10-min warm-up, followed by 30 min of resistance training (biceps curls, triceps exercises, chest press, plank, crunches, squats, lunges, hamstring, and quadriceps curls), and ending with a 10-min cool-down. Repetitions are logged weekly for assessment.

medical treatment

Drug

Each woman in the three groups will receive medical treatment (metformin tablets) for eight weeks and the dose will prescribed by the gynecologist during the first visit. Patients will be asked to attend the clinic each month for routine monitoring.

Other names: Metformin tablets

Primary outcomes

  1. HOM-IR calculation

    Time frame: 8 weeks

    It is calculated from fasting glucose and fasting insulin. Different studies provide slightly different ranges for HOM-IR. But they all agree that the higher HOM-IR gets , the more insulin resistance are.

    Less than 1 : optimal insulin resistance. Above 1.9 : early insulin resistance. Above 2.9 : significant insulin resistance.

Secondary outcomes

  1. Waist circumference measurement

    Time frame: 8 weeks

    It will be taken around the abdomen at the level of the umbilicus to measure waist circumference correctly. This will be performed before and after treatment for all groups (A,B and C).

  2. Waist/ hip ratio assessment

    Time frame: 8 weeks

    It will be calculated as waist circumference in centimeters divided by hip circumference in centimeters. This will be performed before and after treatment for all groups (A,B and C).

  3. Weight measurement

    Time frame: 8 weeks

    It will be measured before and after treatment for all groups (A,B and C), using the InBody GS 6.5 B.

  4. Body mass index (BMI) measurement

    Time frame: 8 weeks

    It will be measured before and after treatment for all groups (A,B and C). The BMI will be calculated by the weight in kilograms divided by square of the height in centimeters according to the formula: BMI = weight (kg)/height2 (m2).

  5. Body fat mass (BFM) measurement

    Time frame: 8 weeks

    It will be measured in kilogram before and after treatment for all groups (A,B and C), using the InBody GS 6.5 B.

  6. Skeletal muscle mass (SMM) measurement

    Time frame: 8 weeks

    It will be measured in kilogram before and after treatment for all groups (A,B and C), using the InBody GS 6.5 B.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 18, 2025
Registry last updated
May 4, 2026

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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