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

Obesity Clinical Trial

— PCOS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04193371
• Other study ID #: PekingUTH TCM
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 6, 2019
• Est. completion date: October 31, 2023

Study information

• Verified date: March 2023
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 106
• Est. completion date: October 31, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• PCOS

Intervention

Other:
• Active acupuncture
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
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
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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing	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	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	total body fat	examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) .	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	body fat and lean ratio	examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) .	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	visceral fat	examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) .	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	basal metabolic rate	examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) .	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	antral follicle count	examined the ovarian morphology with the B-ultrasound	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	sex hormone binding globulin (SHBG)	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	anti-mullerian hormone (AMH)	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	follicle stimulating hormone (FSH)	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	luteinizing hormone (LH)	examined with the blood sample	After 4 months of intervention Follow-up 4 months after last treatment.,
Secondary	Progestin (P)	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	Estrogen (E2)	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	Androgen(T)	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	Androstenedione (A2)	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	HOMA-IR	will be assessed during the oral glucose tolerance test (OGTT) , calculation of HOMA-IR: [fasting insulin (µU/mL) × fasting glucose (mmol/L)] / 22.5)	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	HOMA- ß	will be assessed during the oral glucose tolerance test (OGTT) ,calculation of HOMA-ß: 20 × fasting insulin (mU/mL) / (fasting plasma glucose (mmol/L) - 3.5	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	glycated hemoglobin ( HbA1c)	The insulin and glucose response in blood	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	total cholesterol	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	triglycerides	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	high density lipoprotein (HDL)	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	low density lipoprotein (LDL)	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	lipometabonomic/lipidomics	Detection with the method of metabonomic in blood, the sample size is about 20 participants in each group.	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	bile acid omics	Detection with the method of metabonomic in blood, the sample size is about 20 participants in each group	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	ß-endorphin	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	5- hydroxytryptamine (5-HT)	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	FerrimanGallwey (FG )value	To determine changes in women's hairy with FG rating scale (0-36 score), the higher, the worse.	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	short form-36 (SF36)	determine the health quality of life by the questionnaire of SF36 (0-100 score), the higher, the better.	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	EuroQol health index scale (EQ-5D)	determine the health quality of life by the questionnaire of EQ-5D (0-100 score), the higher, the better.	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	polycystic ovary syndrome questionnaire (PCOSQ);	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.	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	Self-Rating Anxiety Scale (SAS)	determine the anxiety level with the questionnaire of SAS (20-100 score), the higher, the worse.	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	Self-Rating Depress Scale (SDS)	determine the depress level with the questionnaire of SDS (20-100 score), the higher, the worse.	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	Body mass index (BMI)	Weight in kilograms divided by the square of her height in meters, reported in kg/m2	Follow-up 4 months after last treatment.
Secondary	Fibroblast growth factor 19(FGF-19)	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	Ghrelin	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	Interleukin 6( IL-6 )	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	Interleukin 8( IL-8 )	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	Interleukin 22( IL-22 )	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	Tumor Necrosis Factor-Alpha (TNF-a)	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	Gamma-Amino Butyric Acid(GABA)	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	dopamine(DA)	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	Glutamate	examined with the blood sample	After 4 months of intervention, Follow-up 4 months after last treatment.
Secondary	proteomics	Detection with the Proteomic techniques in blood, the sample size is about 30 participants in each group.	After 4 months of intervention
Secondary	branched-chain amino acids	examined with the blood sample, the sample size is about 30 participants in each group.	After 4 months of intervention