Clinical trial · Interventional
Acupuncture for Insulin Resistance in Women With Polycystic Ovary Syndrome
Effects of Acupuncture on Homeostatic Model Assessment of Insulin Resistance in Women With Polycystic Ovary Syndrome: Study Protocol for a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
This two-stage clinical research programme aims to evaluate the preliminary effectiveness and safety of acupuncture for improving insulin resistance in women with polycystic ovary syndrome (PCOS). Phase I will be a prospective, single-centre, open-label, single-arm exploratory trial involving 20 participants, all of whom will receive active acupuncture plus lifestyle management. Acupuncture will be administered three times per week for 12 weeks, followed by a 12-week follow-up period. The study will primarily assess safety, tolerability, feasibility, and the preliminary change in the homeostatic model assessment of insulin resistance (HOMA-IR) from baseline to Week 12. The effect size and variability of HOMA-IR change, together with safety, adherence, and dropout data obtained from Phase I, will be used to determine the sample size and finalize the design of Phase II. Phase II is planned as a prospective, multicentre, parallel, randomized, participant- and outcome assessor-blinded, sham-controlled trial comparing active acupuncture plus lifestyle management with sham acupuncture plus lifestyle management to confirm the effectiveness and safety of the intervention.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Active Acupuncture | Procedure | — | UNRESOLVED |
| Lifestyle Management | Behavioral | — | UNRESOLVED |
| Sham Acupuncture | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- SHAM_COMPARATOR
- label
- Sham Acupuncture Plus Lifestyle Management
- description
- Participants receive sham acupuncture for 30 minutes, three times weekly for 12 weeks (up to 36 sessions). Sterile 0.20 × 20 mm needles are inserted superficially (\<5 mm) at non-acupuncture and non-meridian points on the shoulder and upper arm, without manual stimulation. Electrodes are attached and the stimulator is set to zero intensity. Participants also receive individualized web- and mobile-assisted lifestyle management, including dietary and physical activity guidance and use of a wearable step counter.
- interventionNames
- Procedure: Sham Acupuncture
- Behavioral: Lifestyle Management
- type
- EXPERIMENTAL
- label
- Active Acupuncture Plus Lifestyle Management
- description
- Participants receive active acupuncture for 30 minutes, three times weekly for 12 weeks (up to 36 sessions), using alternating standardized sets of acupuncture points. Needles are inserted 15-40 mm and manually stimulated to elicit de qi. Selected points receive 2-Hz electroacupuncture at a comfortable intensity of 0.1-2.0 mA; other needles are manually stimulated every 10 minutes. Participants also receive individualized web- and mobile-assisted lifestyle management, including dietary and physical activity guidance and use of a wearable step counter.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Age 20 to 40 years * BMI ≥ 24 and \<40 * PCOS diagnosis according to Rotterdam criteria 2003 \[23\] 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 * Voluntarily participate in this research project and sign the informed consent form Exclusion Criteria: * Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia, thyroid dysfunction and hyperprolactinemia * Type I diabetes or not well controlled type II diabetes * Pharmacological or acupuncture treatment within past 3 months * Pregnancy or breastfeeding in the last 6 months * Blood pressure \>160/100mmHg * Daily smoking and alcoholic intake * Mental problems * Language or mental disorders, or inability to understand the experimental content
References
Publications (0)
Data not yet available