Obesity, Overweight, PCOS
Conditions
Keywords
PCOS, Overweight, Obesity, Acupuncture, Lifestyle management
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.
Interventions
OTHERActive 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.
OTHERSham 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.
OTHERLifestyle 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.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
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
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| body fat and lean ratio | After 4 months of intervention， Follow-up 4 months after last treatment. | examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) . |
| visceral fat | After 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 rate | After 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 count | After 4 months of intervention， Follow-up 4 months after last treatment. | examined the ovarian morphology with the B-ultrasound |
| sex hormone binding globulin (SHBG) | After 4 months of intervention， Follow-up 4 months after last treatment. | examined with the blood sample |
| anti-mullerian hormone (AMH) | 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 |
| luteinizing hormone (LH) | 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 |
| Androstenedione (A2) | After 4 months of intervention， Follow-up 4 months after last treatment. | examined with the blood sample |
| HOMA-IR | 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) |
| HOMA- β | 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 |
| glycated hemoglobin ( HbA1c) | After 4 months of intervention， Follow-up 4 months after last treatment. | The insulin and glucose response in blood |
| total cholesterol | After 4 months of intervention， Follow-up 4 months after last treatment. | examined with the blood sample |
| triglycerides | 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 |
| low density lipoprotein (LDL) | After 4 months of intervention， Follow-up 4 months after last treatment. | examined with the blood sample |
| lipometabonomic/lipidomics | 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. |
| bile acid omics | 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 |
| β-endorphin | After 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 |
| FerrimanGallwey (FG )value | 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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 |
| Fibroblast growth factor 19(FGF-19) | After 4 months of intervention， Follow-up 4 months after last treatment. | examined with the blood sample |
| Ghrelin | After 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 |
| Interleukin 8( IL-8 ) | After 4 months of intervention， Follow-up 4 months after last treatment. | examined with the blood sample |
| Interleukin 22( IL-22 ) | 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 |
| total body fat | After 4 months of intervention， Follow-up 4 months after last treatment. | examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) . |
| dopamine（DA） | After 4 months of intervention， Follow-up 4 months after last treatment. | examined with the blood sample |
| Glutamate | After 4 months of intervention， Follow-up 4 months after last treatment. | examined with the blood sample |
| proteomics | After 4 months of intervention | Detection with the Proteomic techniques in blood, the sample size is about 30 participants in each group. |
| branched-chain amino acids | After 4 months of intervention | examined with the blood sample, the sample size is about 30 participants in each group. |
| Gamma-Amino Butyric Acid(GABA) | After 4 months of intervention， Follow-up 4 months after last treatment. | examined with the blood sample |
Countries
China
Outcome results
None listed