Clinical trial NCT02026323: The Effect of Acupuncture on Insulin Sensitivity Polycystic Ovary Syndrome
Official title: Effect of Acupuncture on Insulin Sensitivity in Women With Polycystic Ovary Syndrome and Insulin Resistance: Study Protocol of a Prospective Observational Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Insulin Resistance
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hyperinsulinemia and insulin resistance play a key role in the pathogenesis of polycystic ovary syndrome (PCOS). Insulin resistance is significantly associated with the long-term risks of metabolic syndrome and cardiovascular disease. Acupuncture with electrical stimulation has in rats with dihydrotestosterone (DHT)-induced PCOS been shown to improve insulin sensitivity. Whether these findings can be translated into women with PCOS has not been investigated. Therefore, this study aims to evaluate whether acupuncture improves insulin sensitivity, ovulation rate and quality of life in women with PCOS. Our hypothesis is that acupuncture with combined manual and low-frequency electrical stimulation of the needles improves insulin resistance, induces ovulation and improves quality of life.

Detailed description: This is a prospective observational study. A total of 112 women with PCOS and insulin resistance will be recruited and randomized into two groups according to their body mass index (BMI), i.e. normal weight (BMI=18.5-23Kg/m2) group and overweight or obese (BMI \> 23Kg/m2) group1. The acupuncture treatment will last for six months, 3 times per week, 30 minutes per treatment. The primary outcome is changes in insulin sensitivity from baseline to after 6 months of acupuncture treatment measured by OGTT.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years.
2. BMI ≥18.5Kg/m2
3. Confirmed diagnosis of PCOS according to the Rotterdam criteria: Oligo-, amenorrhea (less than 8 cycles per year) or/clinical or biochemical hyperandrogenism and/or polycystic ovarian morphology.
4. IR defined by the homeostatic model assessment (HOMA-IR: fasting insulin x fasting glucose/22.5) and 2.14 will be used as the cut off 33.
5. No desire of children and using barrier methods of contraception for 1 year.
6. Willing to sign the consent form

Exclusion Criteria:

1. With other endocrine disorders such as hyperprolactinemia (defined as two prolactin levels at least one week apart 25 ng/mL or greater or as determined by local normative values), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone \<3nmol/L), and androgen secreting tumors.
2. Patients with FSH levels \> 15 mIU/mL. A normal level within the last year is adequate for entry.
3. Patients with uncorrected thyroid disease (defined as TSH \< 0.2 mIU/mL or \>5.5 mIU/mL). A normal level within the last year is adequate for entry.
4. Patients diagnosed with Type I diabetes, or Type I and Type II patients who receiving antidiabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas likely to confound the effects of study medication; patients currently receiving metformin for a diagnosis of Type I or Type II diabetes or for PCOS are also specifically excluded.
5. Patients with suspected Cushing's syndrome.
6. Use of hormonal or other medication including Chinese Herbal prescriptions which may affect the outcome at least in the past 3 months.
7. Pregnancy within the last 6 weeks.
8. Post-abortion or postpartum within last 6 weeks.
9. Breastfeeding within the last 6 months.
10. Patients received Acupuncture treatment related to PCOS within the last 2 months.
11. Patients who have undergone a bariatric surgery procedure in the recent past (\<12 months) and are in a period of acute weight loss.
12. Patients with known congenital adrenal hyperplasia.
13. Not willing to give written consent to the study.

Primary outcomes:
measure: HOMA-IR
timeFrame: baseline,treat for 3 and 6 month ,3 or 6 month follow-up
Secondary outcomes:
measure: FSH
timeFrame: baseline,up to 6 month,the follow-up of 3 or 6 month
measure: LH
timeFrame: baseline,up to 6 month,the follow-up of 3 or 6 month
measure: Androgen
timeFrame: baseline,up to 6 month,the follow-up of 3 or 6 month
measure: Progesterone
timeFrame: baseline,up to 6 month,the follow-up of 3 or 6 month
measure: Prolactin
timeFrame: baseline,up to 6 month,the follow-up of 3 or 6 month
measure: Estradiol
timeFrame: baseline,up to 6 month,the follow-up of 3 or 6 month
measure: dehydroepiandrosterone(sodium)sulfate
timeFrame: baseline,up to 6 month,the follow-up of 3 or 6 month
measure: sex hormone binding globulin
timeFrame: baseline,up to 6 month,the follow-up of 3 or 6 month
measure: c-peptide
timeFrame: baseline,up to 6 month,the follow-up of 3 or 6 month
measure: Apoa1
timeFrame: baseline,up to 6 month,the follow-up of 3 or 6 month
measure: ApoB
timeFrame: baseline,up to 6 month,the follow-up of 3 or 6 month
measure: TC
timeFrame: baseline,up to 6 month,the follow-up of 3 or 6 month
measure: TG
timeFrame: baseline,up to 6 month,the follow-up of 3 or 6 month
measure: glycosylated hemoglobin
timeFrame: baseline,up to 6 month,the follow-up of 3 or 6 month
measure: Questionnaire investigation
timeFrame: baseline,up to 6 month,the follow-up of 3 or 6 month
measure: Transvaginal ultrasound
timeFrame: baseline,up to 6 month,the follow-up of 3 or 6 month
Other outcomes:
measure: Body composition(weight,height,waist circumference,hip circumference)
timeFrame: baseline,every month in treatment,the follow-up of 3 or 6 month
Locations:
city: Guangzhou
country: China
facility: The first affiliated hospital of Guangzhou Medical University
state: Guangdong
Study officials:
affiliation: Study sponsor
name: Hongxia HX Ma, Dorctor
role: STUDY_CHAIR
References:
citation: Zheng YH, Wang XH, Lai MH, Yao H, Liu H, Ma HX. Effectiveness of abdominal acupuncture for patients with obesity-type polycystic ovary syndrome: a randomized controlled trial. J Altern Complement Med. 2013 Sep;19(9):740-5. doi: 10.1089/acm.2012.0429. Epub 2013 May 15.
citation: Zheng Y, Stener-Victorin E, Ng EH, Li J, Wu X, Ma H. How does acupuncture affect insulin sensitivity in women with polycystic ovary syndrome and insulin resistance? Study protocol of a prospective pilot study. BMJ Open. 2015 May 3;5(4):e007757. doi: 10.1136/bmjopen-2015-007757.