Clinical trial NCT06882291: Intermittent Fasting Diet Versus Resistive Exercise Program on Insulin Resistance in Obese Women With P.C.O.S
Official title: Intermittent Fasting Diet Versus Resistive Exercise Program on Insulin Resistance in Obese Women With P.C.O.S
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 72
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: HOM-IR calculation
timeFrame: 8 weeks
Secondary outcomes:
measure: Waist circumference measurement
timeFrame: 8 weeks
measure: Waist/ hip ratio assessment
timeFrame: 8 weeks
measure: Weight measurement
timeFrame: 8 weeks
measure: Body mass index (BMI) measurement
timeFrame: 8 weeks
measure: Body fat mass (BFM) measurement
timeFrame: 8 weeks
measure: Skeletal muscle mass (SMM) measurement
timeFrame: 8 weeks
Other outcomes:
Locations:
city: 'Ezbet el-Sharika el-Miṣrîya
country: Egypt
facility: Mashtoul Elsouq general Hospital
Study officials:
affiliation: Professor, Cairo university
name: Soheir Mahmoud Elkosery, PhD
role: STUDY_CHAIR
References: