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

NCT06882291 | Completed

• 1 other identifier: P.T.REC/012/005568
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• HOM-IR calculation

  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.

  8 weeks

Secondary Outcomes (6)

• Waist circumference measurement

  8 weeks

• Waist/ hip ratio assessment

  8 weeks

• Weight measurement

  8 weeks

• Body mass index (BMI) measurement

  8 weeks

• Body fat mass (BFM) measurement

  8 weeks

Study Arms (3)

Intermittent fasting diet + medical treatment

EXPERIMENTAL

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.

Other: Intermittent fasting diet; Drug: Medical treatment

Resistive exercise program + medical treatment

EXPERIMENTAL

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.

Other: Resistive exercise program; Drug: Medical treatment

Medical treatment

ACTIVE COMPARATOR

This group will consist of 24 obese PCOS women who will receive a medical treatment only.

Drug: Medical treatment

Interventions

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.

Intermittent fasting diet + medical treatment

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.

Resistive exercise program + medical treatment

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.

Also known as: Metformin tablets

Intermittent fasting diet + medical treatment; Medical treatment; Resistive exercise program + medical treatment

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Mashtoul Elsouq general Hospital

‘Ezbet el-Sharika el-Miṣrîya, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Soheir Mahmoud Elkosery, PhD

  Professor, Cairo university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 18, 2025
• Study Start: March 20, 2025
• Primary Completion: September 20, 2025
• Study Completion: September 30, 2025
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

EG (1)