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Trial Title: A Randomized Controlled Trial of Acupuncture for Insulin Resistance in Patients With Polycystic Ovary Syndrome

NCT ID: NCT06306417

Condition: Polycystic Ovary Syndrome (PCOS)

Conditions: Official terms:
Polycystic Ovary Syndrome
Insulin Resistance
Syndrome

Conditions: Keywords:
insulin resistance

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Participant)

Intervention:

Intervention type: Other
Intervention name: lifestyle intervention
Description: lifestyle intervention
Arm group label: Experimental group
Arm group label: control group

Intervention type: Device
Intervention name: acupuncture
Description: acupuncture
Arm group label: Experimental group

Intervention type: Device
Intervention name: Sham acupuncture
Description: Sham acupuncture
Arm group label: control group

Summary: To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture plus lifestyle management (treatment group), 2) placebo plus lifestyle management (control group) in the treatment of insulin resistance in PCOS patients.

Detailed description: A prospective, randomized controlled trial design was used to select women with polycystic ovary syndrome as the research subjects. 144 subjects who met the inclusion and exclusion criteria were randomly divided into an acupuncture plus lifestyle intervention group (treatment group) and a placebo plus lifestyle intervention group (control group). The differences in glucose metabolism and reproductive endocrinology were compared between the two groups. 1. To verify the efficacy and safety of acupuncture intervention on insulin resistance in PCOS; 2. To explore the effects of acupuncture on androgen and lipid levels, ovarian function, reproductive dysfunction, mood and quality of life in women with PCOS.

Criteria for eligibility:
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.

Gender: Female

Minimum age: 18 Years

Maximum age: 40 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Peking University third hospital

Address:
City: Beijing
Country: China

Status: Recruiting

Contact:
Last name: Haolin Zhang, PHD

Phone: +8615611963539
Email: zoe@bjmu.edu.cn

Start date: September 28, 2023

Completion date: August 30, 2025

Lead sponsor:
Agency: Peking University Third Hospital
Agency class: Other

Source: Peking University Third Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06306417

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