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Not yet recruiting NCT07708766

Effect of High Intensity Interval Training on Insulin Resistance in Polycystic Ovarian Syndrome

No phase Interventional Polycystic Ovary Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intermittent fasting diet group, High intensity interval training.
Who it may be relevant to
Registry conditions: Polycystic Ovary Syndrome. Basic parameters: 20 years — 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

Detailed description

Women with polycystic ovarian syndrome (PCOS) are at increased risk for glucose intolerance, dyslipidemia, subfertility, obstetric complications and psychosexual disorders.

The prevalence of insulin resistance in PCOS can range from 44% to 70%. Studies have indicated that worsening of insulin resistance over time in obese women with PCOS is associated with early development of diabetes mellitus type 2.

Interventions like oral contraceptive pills give the higher risk of endometrial cancer for women with PCOS. However, lifestyle correction appears to be the sustainable therapy of PCOS.

High-intensity interval training (HIIT) consists of short periods of intense exercise (80% of maximal heart rate) alternated with periods of active recovery or rest. It is a relatively time-efficient training strategy to improve metabolic health and has been considered more enjoyable than moderate-to-vigorous intensity continuous training HIIT increases skeletal muscle oxidative capacity and appears to be effective in improving insulin sensitivity, particularly in those at increased risk type 2 diabetes mellitus.

Intermittent fasting had a powerful effect on improvement of glucose metabolism by lowering insulin resistance, improvement of systemic inflammatory diseases and even expansion of life span.

So, this study will be conducted to provide new evidences and information about the efficacy of high intensity interval training on insulin resistance in women suffering from PCOS, to manage this problem upon them and add new information to the field of physical therapy.

Interventions

  • Other Intermittent fasting diet group
    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 da
  • Other High intensity interval training
    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

Primary outcome measures

  • Body weight [Time frame: 12 weeks]
  • Body mass index [Time frame: 12 weeks]
  • Waist circumference [Time frame: 12 weeks]
  • Hip circumference [Time frame: 12 weeks]
  • Waist/ hip ratio [Time frame: 12 weeks]
  • Oral glucose tolerance test [Time frame: 12 weeks]
  • Fasting plasma insulin [Time frame: 12 weeks]
  • Glucose /insulin ratio [Time frame: 12 weeks]
  • Homeostasis Model Assessment (HOMA IR) [Time frame: 12 weeks]
Secondary outcome measures (1)
  • Assessment of quality of life [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Hager Tharwat Mohamed — Cairo

Identifiers

NCT: NCT07708766 · P.T.REC/012/005735

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗