A Randomized Controlled Trial of Acupuncture for Insulin Resistance in Patients With Polycystic Ovary Syndrome
- Conditions
- Polycystic Ovary Syndrome (PCOS)
- Interventions
- Other: lifestyle interventionDevice: acupunctureDevice: Sham acupuncture
- Registration Number
- NCT06306417
- Lead Sponsor
- Peking University Third Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 144
- 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 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.
- Type I diabetes or not well controlled type II diabetes
- Stage 2 hypertension (resting blood pressure ≥160/100mmHg)
- Psychiatric diagnoses or using psychiatric medications including antidepressants
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group acupuncture acupuncture control group lifestyle intervention sham acupuncture control group Sham acupuncture sham acupuncture Experimental group lifestyle intervention acupuncture
- Primary Outcome Measures
Name Time Method HOMA-IR baseline and after 4 months calculation of HOMA-IR: \[fasting insulin (μU/mL) × fasting glucose (mmol/L)\] / 22.5)
\[Time Frame: Baseline\]
- Secondary Outcome Measures
Name Time Method Prolactin (PRL) baseline and after 4 months Examined with the blood sample
Progestin (P) baseline and after 4 months Examined with the blood sample
high density lipoprotein (HDL) baseline and after 4 months Examined with the blood sample
low density lipoprotein (LDL) baseline and after 4 months Examined with the blood sample
waist to hip ratio(WHR) baseline and after 4 months calculation of WHR: waist circumference(cm)/ hip circumference(cm)
glycosylated hemoglobin level baseline and after 4 months Examined with the blood sample
Follicle stimulating hormone (FSH) baseline and after 4 months Examined with the blood sample
luteinizing hormone (LH) baseline and after 4 months Examined with the blood sample
Estrogen (E2) baseline and after 4 months Examined with the blood sample
Free testosterone index (FAI) baseline and after treatment testosterone (nmol/ml) ×100 / SHBG (nmol/ml).
number of follicles baseline and after 4 months observed by B-ultrasound
AUC insulin baseline and after 4 months during oral glucose tolerance test (OGTT), AUCarea under the glucose tolerance curve
Bile acidomics baseline and after 4 months Quantitative detection of bile acids in blood and feces by targeted metabolomics (ultra-performance liquid chromatography-time-of-flight mass spectrometry).
polycystic ovary syndrome questionnaire, PCOSQ baseline and after 4 months Mood, weight, body hair, acne, infertility, menstrual symptoms, and menstrual predictability in women with PCOS
uterine size baseline and after 4 months observed by B-ultrasound
Hirsutism(FG score >4）, acne and early alopecia baseline and after 4 months general condition
Androgen(T) baseline and after 4 months Examined with the blood sample
Anti-mullerian hormone (AMH) baseline and after 4 months Examined with the blood sample
Sex hormone-binding globulin (SHBG) baseline and after 4 months Examined with the blood sample
total cholesterol baseline and after 4 months Examined with the blood sample
Self-Rating Anxiety Scale (SAS) baseline and after 4 months determine the anxiety level with the questionnaire of SAS (20-100 score), the higher, the worse.
Self-Rating Depress Scale (SDS) baseline and after 4 months determine the depress level with the questionnaire of SDS (20-100 score), the higher, the worse
triglycerides baseline and after 4 months Examined with the blood sample
Metagenomics and 16S rDNA sequencing analysis baseline and after 4 months gDNA was extracted by fecal genomic DNA kit and sequenced by Illumina Hiseq 4000.
short form-36 (SF36) baseline and after 4 months determine the health quality of life by the questionnaire of SF36 (0-100 score), the higher, the better
BMI baseline and after 4 months calculation:BMI=weight(kg)/height(m)\^2
endometrial thickness baseline and after 4 months observed by B-ultrasound
ovarian size baseline and after 4 months baseline and after 4 months, explained by 3 diameters: length(cm) \* width(cm) \* height(cm)
Fat% baseline and after 4 months examined by body composition analyzer
Trial Locations
- Locations (1)
Peking University third hospital
🇨🇳Beijing, China