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

Polycystic Ovary Syndrome (PCOS) Clinical Trial

Official title:

Department of Traditional Chinese Medicine (TCM), Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing 100191, China.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06306417
• Other study ID #: PKUTH TCM
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2023
• Est. completion date: August 30, 2025

Study information

• Verified date: January 2024
• Source: Peking University Third Hospital
• Contact: Haolin Zhang, PHD
• Phone: 15611963539
• Email: zoe[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: August 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance
• Polycystic Ovary Syndrome
• Polycystic Ovary Syndrome (PCOS)
• Syndrome

Intervention

Other:
• lifestyle intervention
lifestyle intervention

Device:
• acupuncture
acupuncture
• Sham acupuncture
Sham acupuncture

Locations

Country	Name	City	State
China	Peking University third hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HOMA-IR	calculation of HOMA-IR: [fasting insulin (µU/mL) × fasting glucose (mmol/L)] / 22.5); [Time Frame: Baseline]	baseline and after 4 months
Secondary	Hirsutism(FG score >4), acne and early alopecia	general condition	baseline and after 4 months
Secondary	AUC insulin	during oral glucose tolerance test (OGTT), AUCarea under the glucose tolerance curve	baseline and after 4 months
Secondary	Follicle stimulating hormone (FSH)	Examined with the blood sample	baseline and after 4 months
Secondary	luteinizing hormone (LH)	Examined with the blood sample	baseline and after 4 months
Secondary	Progestin (P)	Examined with the blood sample	baseline and after 4 months
Secondary	Estrogen (E2)	Examined with the blood sample	baseline and after 4 months
Secondary	Prolactin (PRL)	Examined with the blood sample	baseline and after 4 months
Secondary	Androgen(T)	Examined with the blood sample	baseline and after 4 months
Secondary	Anti-mullerian hormone (AMH)	Examined with the blood sample	baseline and after 4 months
Secondary	Sex hormone-binding globulin (SHBG)	Examined with the blood sample	baseline and after 4 months
Secondary	Free testosterone index (FAI)	testosterone (nmol/ml) ×100 / SHBG (nmol/ml).	baseline and after treatment
Secondary	total cholesterol	Examined with the blood sample	baseline and after 4 months
Secondary	triglycerides	Examined with the blood sample	baseline and after 4 months
Secondary	high density lipoprotein (HDL)	Examined with the blood sample	baseline and after 4 months
Secondary	low density lipoprotein (LDL)	Examined with the blood sample	baseline and after 4 months
Secondary	Bile acidomics	Quantitative detection of bile acids in blood and feces by targeted metabolomics (ultra-performance liquid chromatography-time-of-flight mass spectrometry).	baseline and after 4 months
Secondary	Metagenomics and 16S rDNA sequencing analysis	gDNA was extracted by fecal genomic DNA kit and sequenced by Illumina Hiseq 4000.	baseline and after 4 months
Secondary	short form-36 (SF36)	determine the health quality of life by the questionnaire of SF36 (0-100 score), the higher, the better	baseline and after 4 months
Secondary	Self-Rating Anxiety Scale (SAS)	determine the anxiety level with the questionnaire of SAS (20-100 score), the higher, the worse.	baseline and after 4 months
Secondary	Self-Rating Depress Scale (SDS)	determine the depress level with the questionnaire of SDS (20-100 score), the higher, the worse	baseline and after 4 months
Secondary	polycystic ovary syndrome questionnaire, PCOSQ	Mood, weight, body hair, acne, infertility, menstrual symptoms, and menstrual predictability in women with PCOS	baseline and after 4 months
Secondary	BMI	calculation:BMI=weight(kg)/height(m)^2	baseline and after 4 months
Secondary	Fat%	examined by body composition analyzer	baseline and after 4 months
Secondary	waist to hip ratio(WHR)	calculation of WHR: waist circumference(cm)/ hip circumference(cm)	baseline and after 4 months
Secondary	glycosylated hemoglobin level	Examined with the blood sample	baseline and after 4 months
Secondary	ovarian size	baseline and after 4 months, explained by 3 diameters: length(cm) * width(cm) * height(cm)	baseline and after 4 months
Secondary	number of follicles	observed by B-ultrasound	baseline and after 4 months
Secondary	uterine size	observed by B-ultrasound	baseline and after 4 months
Secondary	endometrial thickness	observed by B-ultrasound	baseline and after 4 months