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

Not Applicable
Active, not recruiting
Conditions
Overweight
Obesity
PCOS
Interventions
Other: Sham acupuncture
Other: Active acupuncture
Other: Lifestyle management
Registration Number
NCT04193371
Lead Sponsor
Peking University Third Hospital
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
Female
Target Recruitment
106
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

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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
control acupuncture + lifestyle managementSham acupunctureParticipants in this group are treated by control acupuncture and lifestyle management for four months and follow up 4 months after the last treatment.
control acupuncture + lifestyle managementLifestyle managementParticipants in this group are treated by control acupuncture and lifestyle management for four months and follow up 4 months after the last treatment.
active acupuncture + lifestyle managementActive acupunctureParticipants in this group are treated by active acupuncture and lifestyle management for 4 months and follow up 4 months after the last treatment.
active acupuncture + lifestyle managementLifestyle managementParticipants in this group are treated by active acupuncture and lifestyle management for 4 months and follow up 4 months after the last treatment.
Primary Outcome Measures
NameTimeMethod
Body mass index (BMI)After 4 months of intervention;

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

Secondary Outcome Measures
NameTimeMethod
body fat and lean ratioAfter 4 months of intervention， Follow-up 4 months after last treatment.

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

sex hormone binding globulin (SHBG)After 4 months of intervention， Follow-up 4 months after last treatment.

examined with the blood sample

total body fatAfter 4 months of intervention， Follow-up 4 months after last treatment.

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

glycated hemoglobin ( HbA1c)After 4 months of intervention， Follow-up 4 months after last treatment.

The insulin and glucose response in blood

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

examined with the blood sample

FerrimanGallwey (FG )valueAfter 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.

Interleukin 22( IL-22 )After 4 months of intervention， Follow-up 4 months after last treatment.

examined with the blood sample

luteinizing hormone (LH)After 4 months of intervention Follow-up 4 months after last treatment.，

examined with the blood sample

high density lipoprotein (HDL)After 4 months of intervention， Follow-up 4 months after last treatment.

examined with the blood sample

short form-36 (SF36)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.

Self-Rating Anxiety Scale (SAS)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.

Body mass index (BMI)Follow-up 4 months after last treatment.

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

branched-chain amino acidsAfter 4 months of intervention

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

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

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

basal metabolic rateAfter 4 months of intervention， Follow-up 4 months after last treatment.

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

antral follicle countAfter 4 months of intervention， Follow-up 4 months after last treatment.

examined the ovarian morphology with the B-ultrasound

anti-mullerian hormone (AMH)After 4 months of intervention， Follow-up 4 months after last treatment.

examined with the blood sample

Progestin (P)After 4 months of intervention， Follow-up 4 months after last treatment.

examined with the blood sample

Estrogen (E2)After 4 months of intervention， Follow-up 4 months after last treatment.

examined with the blood sample

Androgen(T)After 4 months of intervention， Follow-up 4 months after last treatment.

examined with the blood sample

low density lipoprotein (LDL)After 4 months of intervention， Follow-up 4 months after last treatment.

examined with the blood sample

lipometabonomic/lipidomicsAfter 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.

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

examined with the blood sample

EuroQol health index scale (EQ-5D)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.

Interleukin 8( IL-8 )After 4 months of intervention， Follow-up 4 months after last treatment.

examined with the blood sample

Tumor Necrosis Factor-Alpha (TNF-α)After 4 months of intervention， Follow-up 4 months after last treatment.

examined with the blood sample

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

examined with the blood sample

proteomicsAfter 4 months of intervention

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

bile acid omicsAfter 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

polycystic ovary syndrome questionnaire (PCOSQ);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.

Fibroblast growth factor 19(FGF-19)After 4 months of intervention， Follow-up 4 months after last treatment.

examined with the blood sample

follicle stimulating hormone (FSH)After 4 months of intervention， Follow-up 4 months after last treatment.

examined with the blood sample

Androstenedione (A2)After 4 months of intervention， Follow-up 4 months after last treatment.

examined with the blood sample

HOMA-IRAfter 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)

HOMA- βAfter 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

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

examined with the blood sample

5- hydroxytryptamine (5-HT)After 4 months of intervention， Follow-up 4 months after last treatment.

examined with the blood sample

Self-Rating Depress Scale (SDS)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.

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

examined with the blood sample

Interleukin 6( IL-6 )After 4 months of intervention， Follow-up 4 months after last treatment.

examined with the blood sample

Gamma-Amino Butyric Acid(GABA)After 4 months of intervention， Follow-up 4 months after last treatment.

examined with the blood sample

dopamine（DA）After 4 months of intervention， Follow-up 4 months after last treatment.

examined with the blood sample

Trial Locations

Locations (1)

Peking University Third Hospital

🇨🇳

Beijing, Beijing, China

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