Clinical trial NCT06306417: A Randomized Controlled Trial of Acupuncture for Insulin Resistance in Patients With Polycystic Ovary Syndrome
Official title: Department of Traditional Chinese Medicine (TCM), Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing 100191, China.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Polycystic Ovary Syndrome (PCOS)
Keywords: insulin resistance
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 144
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: HOMA-IR
timeFrame: baseline and after 4 months
Secondary outcomes:
measure: Hirsutism(FG score >4）, acne and early alopecia
timeFrame: baseline and after 4 months
measure: AUC insulin
timeFrame: baseline and after 4 months
measure: Follicle stimulating hormone (FSH)
timeFrame: baseline and after 4 months
measure: luteinizing hormone (LH)
timeFrame: baseline and after 4 months
measure: Progestin (P)
timeFrame: baseline and after 4 months
measure: Estrogen (E2)
timeFrame: baseline and after 4 months
measure: Prolactin (PRL)
timeFrame: baseline and after 4 months
measure: Androgen(T)
timeFrame: baseline and after 4 months
measure: Anti-mullerian hormone (AMH)
timeFrame: baseline and after 4 months
measure: Sex hormone-binding globulin (SHBG)
timeFrame: baseline and after 4 months
measure: Free testosterone index (FAI)
timeFrame: baseline and after treatment
measure: total cholesterol
timeFrame: baseline and after 4 months
measure: triglycerides
timeFrame: baseline and after 4 months
measure: high density lipoprotein (HDL)
timeFrame: baseline and after 4 months
measure: low density lipoprotein (LDL)
timeFrame: baseline and after 4 months
measure: Bile acidomics
timeFrame: baseline and after 4 months
measure: Metagenomics and 16S rDNA sequencing analysis
timeFrame: baseline and after 4 months
measure: short form-36 (SF36)
timeFrame: baseline and after 4 months
measure: Self-Rating Anxiety Scale (SAS)
timeFrame: baseline and after 4 months
measure: Self-Rating Depress Scale (SDS)
timeFrame: baseline and after 4 months
measure: polycystic ovary syndrome questionnaire, PCOSQ
timeFrame: baseline and after 4 months
measure: BMI
timeFrame: baseline and after 4 months
measure: Fat%
timeFrame: baseline and after 4 months
measure: waist to hip ratio(WHR)
timeFrame: baseline and after 4 months
measure: glycosylated hemoglobin level
timeFrame: baseline and after 4 months
measure: ovarian size
timeFrame: baseline and after 4 months
measure: number of follicles
timeFrame: baseline and after 4 months
measure: uterine size
timeFrame: baseline and after 4 months
measure: endometrial thickness
timeFrame: baseline and after 4 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University third hospital
Study officials:
affiliation: Peking University Third Hospital
name: Haolin Zhang
role: STUDY_DIRECTOR
References: