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NCT Number: NCT04193371

Effects of Acupuncture on Body Mass Index in Overweight and Obese Women With Polycystic Ovary Syndrome (PCOS )

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.

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Key information

Conditions

PCOS Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active acupuncture

Other

The rationale of the active acupuncture protocol is based on Western Medical Acupuncture theories and follows CONSORT and STRICTA protocols. All patients received acupuncture treatment for 30 minutes three times a week, with a maximum of 48 acupuncture treatments.

Sham Acupuncture

Other

In the sham acupuncture protocol, 2 needles were inserted superficially to a depth of less than 5 mm, 1 in each shoulder and 1 in each upper arm at nonacupuncture and non-meridian points, and then, 4 needles were attached to electrodes and the stimulator was turned on to mimic the active acupuncture but with zero intensity, no electrical stimulation. They also received the treatment for 30 minutes three times a week and a maximum of 48 treatments.

Lifestyle management

Other

All women will receive lifestyle management before randomization after baseline measurements. The lifestyle management assisted by a PCOS lifestyle management system (Invention patent, ZL 2015 1 0500978.9).

All participants will get a step-counter for daily use and physical exercise diary for daily reporting of exercise: number of steps, type of activity, intensity and time (minutes). Once a week each participant receive a SMS in which they report the activity during the week.

Primary outcomes

  1. Body mass index (BMI)

    Time frame: After 4 months of intervention;

    PCOS's weight in kilograms divided by the square of her height in meters, reported in kg/m2

Secondary outcomes

  1. total body fat

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) .

  2. body fat and lean ratio

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) .

  3. visceral fat

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) .

  4. basal metabolic rate

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) .

  5. antral follicle count

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined the ovarian morphology with the B-ultrasound

  6. sex hormone binding globulin (SHBG)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  7. anti-mullerian hormone (AMH)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  8. follicle stimulating hormone (FSH)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  9. luteinizing hormone (LH)

    Time frame: After 4 months of intervention Follow-up 4 months after last treatment.，

    examined with the blood sample

  10. Progestin (P)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  11. Estrogen (E2)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  12. Androgen(T)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  13. Androstenedione (A2)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  14. HOMA-IR

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    will be assessed during the oral glucose tolerance test (OGTT) , calculation of HOMA-IR: [fasting insulin (μU/mL) × fasting glucose (mmol/L)] / 22.5)

  15. HOMA- β

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    will be assessed during the oral glucose tolerance test (OGTT) ,calculation of HOMA-β: 20 × fasting insulin (mU/mL) / (fasting plasma glucose (mmol/L) - 3.5

  16. glycated hemoglobin ( HbA1c)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    The insulin and glucose response in blood

  17. total cholesterol

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  18. triglycerides

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  19. high density lipoprotein (HDL)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  20. low density lipoprotein (LDL)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  21. lipometabonomic/lipidomics

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    Detection with the method of metabonomic in blood, the sample size is about 20 participants in each group.

  22. bile acid omics

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    Detection with the method of metabonomic in blood, the sample size is about 20 participants in each group

  23. β-endorphin

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  24. 5- hydroxytryptamine (5-HT)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  25. FerrimanGallwey (FG )value

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    To determine changes in women's hairy with FG rating scale (0-36 score), the higher, the worse.

  26. short form-36 (SF36)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    determine the health quality of life by the questionnaire of SF36 (0-100 score), the higher, the better.

  27. EuroQol health index scale (EQ-5D)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    determine the health quality of life by the questionnaire of EQ-5D (0-100 score), the higher, the better.

  28. polycystic ovary syndrome questionnaire (PCOSQ);

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    determine the Effects of PCOS specific symptoms on the participants by the questionnaire of and polycystic ovary syndrome questionnaire (PCOSQ)(26-182 score); the higher, the better.

  29. Self-Rating Anxiety Scale (SAS)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    determine the anxiety level with the questionnaire of SAS (20-100 score), the higher, the worse.

  30. Self-Rating Depress Scale (SDS)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    determine the depress level with the questionnaire of SDS (20-100 score), the higher, the worse.

  31. Body mass index (BMI)

    Time frame: Follow-up 4 months after last treatment.

    Weight in kilograms divided by the square of her height in meters, reported in kg/m2

  32. Fibroblast growth factor 19(FGF-19)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  33. Ghrelin

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  34. Interleukin 6( IL-6 )

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  35. Interleukin 8( IL-8 )

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  36. Interleukin 22( IL-22 )

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  37. Tumor Necrosis Factor-Alpha (TNF-α)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  38. Gamma-Amino Butyric Acid(GABA)

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  39. dopamine（DA）

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  40. Glutamate

    Time frame: After 4 months of intervention， Follow-up 4 months after last treatment.

    examined with the blood sample

  41. proteomics

    Time frame: After 4 months of intervention

    Detection with the Proteomic techniques in blood, the sample size is about 30 participants in each group.

  42. branched-chain amino acids

    Time frame: After 4 months of intervention

    examined with the blood sample, the sample size is about 30 participants in each group.

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Department of Traditional Chinese Medicine (TCM), Peking University Third Hospital, Beijing, China

Acronym: PCOS

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2019
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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