NCT07708766

Brief Summary

This study will be conducted to investigate the effect of high- intensity interval training on insulin resistance in polycystic ovarian syndrome.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Jul 2026Jan 2027

First Submitted

Initial submission to the registry

July 11, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

July 20, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2027

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2027

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 11, 2026

Last Update Submit

July 11, 2026

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (9)

  • Body weight

    Body weight will be measured by using weight and height scale before and after treatment program.

    12 weeks

  • Body mass index

    It will be calculated by dividing weight in kilograms divided by height meter square.

    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.

    12 weeks

  • Hip circumference

    Hip circumference will be measured at the widest part of the hip using the tape measurement.

    12 weeks

  • Waist/ hip ratio

    Waist /hip ratio will be calculated by dividing waist circumference by hip circumference.

    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.

    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.

    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.

    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.

    12 weeks

Secondary Outcomes (1)

  • Assessment of quality of life

    12 weeks

Study Arms (2)

Intermittent fasting diet group

ACTIVE COMPARATOR

The participants will follow intermittent fasting diet only for 12 weeks

Other: Intermittent fasting diet group

High Intensity Interval Training and intermittent fasting diet group

EXPERIMENTAL

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 groupOther: High intensity interval training

Interventions

Intermittent fasting diet groupOTHER

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).

High Intensity Interval Training and intermittent fasting diet groupIntermittent fasting diet group
High intensity interval trainingOTHER

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.

High Intensity Interval Training and intermittent fasting diet group

Eligibility Criteria

Age20 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Obese women with polycystic Ovarian Syndrome (PCOS) as clinically diagnosed by the gynecologist.
  • Their ages will be ranged from 20 to 35 years old.
  • Their body mass index will be ranged from 30-40 kg/m2.
  • Their waist/hip ratio will be \> 0.8.
  • All of them should have at least two criteria of the Rotterdam diagnostic criteria of PCOS.

You may not qualify if:

  • Cushing syndrome, diabetes mellitus.
  • Thyroid dysfunction.
  • Hypothalamic amenorrhea, ovarian hyperplasia.
  • Respiratory, renal and liver dysfunction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hager Tharwat Mohamed

Cairo, Egypt

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Azza Nashed, Professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Hagar Mohamed

CONTACT

01141667742hagertharwat20172018@gmail.com

Mohamed Abo Eleinien, Professor

CONTACT

01001414404Drfawzygyna61@gmail.com

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

July 11, 2026

First Posted

July 16, 2026

Study Start

July 20, 2026

Primary Completion (Estimated)

January 15, 2027

Study Completion (Estimated)

January 25, 2027

Last Updated

July 16, 2026

Record last verified: 2026-07

Locations

EG(1)