Acupuncture for insulin resistance in women with PCOS
Department of Traditional Chinese Medicine (TCM), Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing 100191, China.
This study is testing if acupuncture along with lifestyle changes can help women with PCOS who have insulin resistance feel better compared to a placebo treatment with lifestyle changes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT06306417 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness and safety of acupuncture combined with lifestyle management compared to a placebo with lifestyle management in treating insulin resistance in women diagnosed with polycystic ovary syndrome (PCOS). A total of 144 participants will be randomly assigned to either the treatment group or the control group. The study aims to assess changes in glucose metabolism, reproductive endocrinology, androgen and lipid levels, ovarian function, and overall quality of life. The trial utilizes a prospective, randomized controlled design to ensure robust results.
Who should consider this trial
Good fit: Ideal candidates are women diagnosed with PCOS who meet the Rotterdam criteria and exhibit symptoms of insulin resistance.
Not a fit: Patients with other endocrine disorders, uncontrolled diabetes, or those on specific psychiatric medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-pharmacological treatment option for improving insulin resistance and related symptoms in women with PCOS.
How similar studies have performed: Previous studies have shown promising results for acupuncture in managing symptoms of PCOS, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * For the PCOS group, PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or ≥12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume ≥10 mL Exclusion Criteria: 1. Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone \< 3nmol/L) thyroid dysfunction and hyperprolactinemia. 2. Type I diabetes or not well controlled type II diabetes 3. Stage 2 hypertension (resting blood pressure ≥160/100mmHg) 4. Psychiatric diagnoses or using psychiatric medications including antidepressants 5. Pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months.
Where this trial is running
Beijing
- Peking University third hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Haolin Zhang, PHD
- Email: zoe@bjmu.edu.cn
- Phone: 15611963539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.