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The Effects of Intermittent Fasting, High-Intensity Interval Training, or Metformin on Patients with Polycystic Ovary Syndrome and Obesity: A Randomized Controlled Trial

The Effects of Intermittent Fasting, High-Intensity Interval Training, or Metformin on Patients with Polycystic Ovary Syndrome and Obesity: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122396
Enrollment
Unknown
Registered
2026-04-13
Start date
2026-04-20
Completion date
Unknown
Last updated
2026-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome

Interventions

TRE group:The subjects underwent a 12-week TRE intervention and completed a 12-week follow-up period.
HIIT group:The subjects underwent a 12-week HIIT intervention and completed a 12-week follow-up period.
MET group:The subjects underwent a 12-week MET intervention and completed a 12-week follow-up period.

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 40 years old; 2. Meets the diagnostic criteria for Rotterdam Polycystic Ovary Syndrome; 3. BMI >= 25 kg/m^2; 4. HOMA-IR >= 2.5; 5. Weight stability (weight fluctuation < 5% in the 3 months prior to enrollment, based on at least 2 objective measurements spaced 4 weeks apart); 6. Voluntary and able to strictly follow the intervention protocol specified in the study.

Exclusion criteria

Exclusion criteria: 1. Diagnosed with diabetes; 2. Has other endocrine diseases besides polycystic ovary syndrome (such as congenital adrenal hyperplasia, Cushing's syndrome, aldosterone excess syndrome, androgen-secreting tumors, hyperprolactinemia, thyroid diseases, premature ovarian failure, etc.) and is undergoing treatment but the condition is not under control; 3. Has taken oral contraceptives, non-luteinizing hormone-releasing hormone drugs, insulin sensitizers (metformin, pioglitazone), drugs affecting weight (such as orlistat, glucocorticoids, etc.) or drugs affecting appetite and gastrointestinal motility within the past 3 months; 4. Has severe liver function impairment (ALT >= 3ULN); renal insufficiency (eGFR = 4 days per week) by the investigator; 18. Has musculoskeletal system diseases or injuries that affect exercise ability (including but not limited to acute and chronic arthritis, osteoarthritis, severe joint pain, recent fractures, tendon/ligament injuries, etc.); 19. Patients whose exercise is prone to induce breathing difficulties; 20. Family history of early-onset unexplained sudden death or known hereditary cardiovascular diseases leading to sudden death; 21. Within the past 3 months, has had an average of >= 150 minutes of high-intensity physical activity per week, assessed by the International Physical Activity Questionnaire (IPAQ); 22. By the investigator's judgment, has other serious systemic diseases or other reasons that make them unsuitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Insulin resistance index;

Secondary

MeasureTime frame
Weight;Body fat distribution;Metabolic risk factors;Sex hormones;Menstrual cycle;Quality of life;

Countries

China

Contacts

Public ContactZhang Haohao

The First Affiliated Hospital of Zhengzhou University

fcczhanghh@zzu.edu.cn+86 138 3810 0727

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026