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

NCT04193371 | Completed

• 1 other identifier: PekingUTH TCM
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS; Overweight; Obesity

Keywords

PCOS; Overweight; Obesity; Acupuncture; Lifestyle management

Outcome Measures

Primary Outcomes (1)

• Body mass index (BMI)

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

  After 4 months of intervention;

Secondary Outcomes (42)

• total body fat

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

• body fat and lean ratio

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

• visceral fat

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

• basal metabolic rate

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

• antral follicle count

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

Study Arms (2)

active acupuncture + lifestyle management

EXPERIMENTAL

Participants in this group are treated by active acupuncture and lifestyle management for 4 months and follow up 4 months after the last treatment.

Other: Active acupuncture; Other: Lifestyle management

control acupuncture + lifestyle management

SHAM COMPARATOR

Participants in this group are treated by control acupuncture and lifestyle management for four months and follow up 4 months after the last treatment.

Other: Sham acupuncture; Other: Lifestyle management

Interventions

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.

active acupuncture + lifestyle management

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.

control acupuncture + lifestyle management

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.

active acupuncture + lifestyle management; control acupuncture + lifestyle management

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: No, the enrollment is based on biological sex
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• haolin zhang

  Peking University Third Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: December 10, 2019
• Study Start: December 6, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: June 22, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)