Clinical trial NCT04193371: Effects of Acupuncture on Body Mass Index in Overweight and Obese Women With Polycystic Ovary Syndrome (PCOS )
Official title: Department of Traditional Chinese Medicine (TCM), Peking University Third Hospital, Beijing, China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PCOS
Overweight
Obesity
Keywords: PCOS
Overweight
Obesity
Acupuncture
Lifestyle management
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 106
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a cross-sectional case-control part and an open-labelled RCT with a comparative effectiveness design. The inter-ventions to be tested are (1) acupuncture during 4 months+lifestylemanagement; (3) sham acupuncture+lifestyle management
Primary purpose: TREATMENT

Brief summary: This is a cross-sectional case-control study combined with a randomised controlled trial (RCT) study. This study aims to compare the effect of acupuncture, with usual care (lifestyle management) for weight control, with BMI (Body Mass index) as main outcome along with improvement of reproductive and metabolic dysfunction in overweight and obese women with PCOS, and further exploring the alteration of lipidomics, bile acid omics, proteomics and branched-chain amino acids between PCOS and the normal controls, and before and after the acupuncture treatment in different gourps.

Detailed description: Polycystic ovary syndrome (PCOS) affects 6 to 18% of all women and is the most common female endocrine and metabolic disorder during the reproductive years. PCOS is characterized by anovulation, hyperandrogenism and metabolic dysfunction.Obesity is \~40% higher in women with PCOS than in healthy women. Overweight results in irregular cycles, insulin resistance and infertility. Acupuncture is assumed to reduce weight The overall hypothesis is that if the Body mass index (BMI) decreased, ovulation can be induced, hyperandrogenism decreased, and insulin sensitivity improved in these women. Although several treatment strategies have shown efficacy, importantly, there is a need for Comparative Effectiveness Research (CER) to strengthen the evidence base for clinical and policy decision-making. Therefore, the investigators aim to compare the effect of acupuncture, with usual care (lifestyle management) for weight loss, and improvement and prevention of reproductive and metabolic dysfunction in overweight and obese women with PCOS. We further compare the differences of PCOS and the controls with the methods of lipidomics, bile acid omics, proteomics and branched-chain amino acids, exploring the mechanisms of acupuncture on PCOS with this kind of methods.

Eligibility criteria: Inclusion Criteria: PCOS

* Age 20 to 40 years
* BMI≥ 24 to \<40
* 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.

Inclusion criteria: Controls

Controls should have BMI\>25to\<40, regular cycles with 28 days±2 days and no signs of hyperandrogenism and PCO morphology on ultrasound

Exclusion Criteria:

* 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
* 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.
* Pregnancy or breastfeeding the last 6 months
* Acupuncture last 3 months
* Daily smoking and alcoholic intake

Primary outcomes:
measure: Body mass index (BMI)
timeFrame: After 4 months of intervention;
Secondary outcomes:
measure: total body fat
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: body fat and lean ratio
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: visceral fat
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: basal metabolic rate
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: antral follicle count
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: sex hormone binding globulin (SHBG)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: anti-mullerian hormone (AMH)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: follicle stimulating hormone (FSH)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: luteinizing hormone (LH)
timeFrame: After 4 months of intervention Follow-up 4 months after last treatment.，
measure: Progestin (P)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: Estrogen (E2)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: Androgen(T)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: Androstenedione (A2)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: HOMA-IR
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: HOMA- β
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: glycated hemoglobin ( HbA1c)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: total cholesterol
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: triglycerides
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: high density lipoprotein (HDL)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: low density lipoprotein (LDL)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: lipometabonomic/lipidomics
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: bile acid omics
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: β-endorphin
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: 5- hydroxytryptamine (5-HT)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: FerrimanGallwey (FG )value
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: short form-36 (SF36)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: EuroQol health index scale (EQ-5D)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: polycystic ovary syndrome questionnaire (PCOSQ);
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: Self-Rating Anxiety Scale (SAS)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: Self-Rating Depress Scale (SDS)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: Body mass index (BMI)
timeFrame: Follow-up 4 months after last treatment.
measure: Fibroblast growth factor 19(FGF-19)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: Ghrelin
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: Interleukin 6( IL-6 )
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: Interleukin 8( IL-8 )
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: Interleukin 22( IL-22 )
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: Tumor Necrosis Factor-Alpha (TNF-α)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: Gamma-Amino Butyric Acid(GABA)
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: dopamine（DA）
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: Glutamate
timeFrame: After 4 months of intervention， Follow-up 4 months after last treatment.
measure: proteomics
timeFrame: After 4 months of intervention
measure: branched-chain amino acids
timeFrame: After 4 months of intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: haolin zhang
role: STUDY_DIRECTOR
References: