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

Not Applicable

Not yet recruiting

• Conditions: Polycystic Ovary Syndrome
• Interventions: Other: Intermittent fasting diet; Other: Resistive exercise program; Drug: Medical treatment

• Registration Number: NCT06882291
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-12
• Study First Submitted QC: 2025-03-12
• Last Update Submitted: 2025-03-12
• Study First Posted: 2025-03-18
• Last Update Posted: 2025-03-18
• Study Start: 2025-03-20
• Primary Completion: 2025-09-20
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intermittent fasting diet + medical treatment	Intermittent fasting diet	This group will consist of 24 obese PCOS women who will receive a program of Intermittent fasting diet for eight weeks and a medical treatment.
Intermittent fasting diet + medical treatment	Medical treatment	This group will consist of 24 obese PCOS women who will receive a program of Intermittent fasting diet for eight weeks and a medical treatment.
Resistive exercise program + medical treatment	Resistive exercise program	This group will consist of 24 obese PCOS women who will receive a resistive exercise program for 30 minutes 5 times/week for eight weeks and a medical treatment.
Resistive exercise program + medical treatment	Medical treatment	This group will consist of 24 obese PCOS women who will receive a resistive exercise program for 30 minutes 5 times/week for eight weeks and a medical treatment.
Medical treatment	Medical treatment	This group will consist of 24 obese PCOS women who will receive a medical treatment only.

Primary Outcome Measures

Name	Time	Method
HOM-IR calculation	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 Outcome Measures

Name	Time	Method
Waist circumference measurement	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).
Waist/ hip ratio assessment	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).
Weight measurement	8 weeks	It will be measured before and after treatment for all groups (A,B and C), using the InBody GS 6.5 B.
Body mass index (BMI) measurement	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).
Body fat mass (BFM) measurement	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.
Skeletal muscle mass (SMM) measurement	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.

Trial Locations

Locations (1)

Mashtoul Elsouq general Hospital; 🇪🇬 'Ezbet el-Sharika el-Miṣrîya, Egypt