Acupuncture for Insulin Resistance in Women With Polycystic Ovary Syndrome

NCT07806656 | Not Yet Recruiting

• 4 other identifiers: PKUTHTCM2026-105825747932024-01-17
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

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

Polycystic Ovary Syndrome

Keywords

Insulin Resistance; Acupuncture; Lifestyle Management; HOMA-IR

Outcome Measures

Primary Outcomes (1)

• Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

  HOMA-IR is calculated from fasting glucose and fasting insulin concentrations. The primary endpoint is the change in HOMA-IR from baseline to the end of the 12-week treatment period.

  Baseline and Week 12 (end of treatment)

Study Arms (2)

Sham Acupuncture Plus Lifestyle Management

SHAM COMPARATOR

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.

Procedure: Sham Acupuncture; Behavioral: Lifestyle Management

Active Acupuncture Plus Lifestyle Management

EXPERIMENTAL

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.

Procedure: Active Acupuncture; Behavioral: Lifestyle Management

Interventions

Sham Acupuncture PROCEDURE

Sham acupuncture is administered for 30 minutes, three times per week for 12 consecutive 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 to mimic active electroacupuncture.

Sham Acupuncture Plus Lifestyle Management

Lifestyle Management BEHAVIORAL

All participants receive individualized lifestyle management beginning at baseline. The program combines face-to-face nutritional consultation with a web- and mobile-based PCOS management platform and wearable step counter. Participants receive individualized dietary and physical activity advice, daily exercise and diet prescriptions, weekly review of weight-loss goals and food diaries, and regular feedback from the research team.

Active Acupuncture Plus Lifestyle Management; Sham Acupuncture Plus Lifestyle Management

Active Acupuncture PROCEDURE

Active acupuncture is administered for 30 minutes, three times per week for 12 consecutive weeks (up to 36 sessions). Two standardized sets of acupuncture points are alternated. Sterile needles are inserted 15-40 mm and manually stimulated to elicit de qi. Selected points receive 2-Hz electroacupuncture (0.3-ms pulse width; approximately 0.1-2.0 mA at a comfortable intensity), while needles not connected to the stimulator are manually stimulated every 10 minutes.

Active Acupuncture Plus Lifestyle Management

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Beijing Haidian Hospital: collaborator

Study Sites (1)

Peking University third hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Haolin Zhang, Doctor

CONTACT

15611963539 Ext.86; zoe@bjmu.edu.cn

Weiqi Zhang, Master

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start: August 20, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 29, 2029
• Last Updated: September 8, 2026

Record last verified: 2026-06

Locations

CN (1)