The RCT of Acupuncture on PCOS Combined With IR

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The objectives of this randomized controlled trial are to compare insulin sensitivity following true acupuncture + placebo metformin (Group 1) vs sham acupuncture + placebo metformin (Group 2) vs sham acupuncture + metformin (Group 3) in women with PCOS and IR.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The First Affiliated Hospital of Guangzhou Medical University
• Collaborators: Karolinska Institutet; The University of Hong Kong
• Treatments: Metformin

Criteria

Inclusion Criteria:

1. Chinese women aged from 18 to 40 years.

2. BMI ≥18.5kg/m2.

3. Confirmed diagnosis of PCOS according to modified Rotterdam criteria in 2003 including at least two of the following three features: ①Oligo-(an intermenstrual interval >35 days or <8 cycles in the past year), amenorrhea (an intermenstrual interval>90 days) and/or; ② polycystic ovarian morphology, i.e. presence of >12 antral follicles (≤ 9mm) and/or ovarian volume >10 ml on transvaginal scanning and/or; ③clinical and/or biochemical hyperandrogenism. Clinical hyperandrogenism in China Mainland is defined as a Ferriman-Gallwey (FG) score ≥5 ; biochemical hyperandrogenism is total testosterone (T) > 2.6 nmol/l and free testosterone ≥6.0 pg/ml.

4. Presence of IR as defined by the homeostatic model assessment (HOMA-IR: [fasting insulin (μU/mL) × fasting glucose (mmol/L)] / 22.5). A value ≥ 2.14 will be considered to be indicative of IR.

5. No immediate fertility wish and willingness to use barrier methods to contraception for one year.

6. Willingness to sign the consent form.

Exclusion Criteria:

1. Exclusion of other endocrine disorders:

① 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.

② Poorly controlled of Type I or Type II diabetes (defined as a HbA1c level > 7.0%), or patients receiving antidiabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas likely to confound the effects of study medication; Patients currently receiving metformin XR (extended release) for a diagnosis of Type I or Type II diabetes or for PCOS are alsoexcluded.

• Cushing's syndrome (define as an archetype of MetS. High glucocorticoid levels lead to muscle, liver and adipocyte insulin resistance. 17-OHCS>55umol/24h or UFC>304nmol/24h) ④ Congenital adrenal hyperplasia (define as patients with known 21-hydroxylase deficiency or other enzyme deficiency leading to the phenotype of congenital adrenal hyperplasia. 17-OHP>10 ng/ml in ACTH 1-24 h excited test (after 60 min)) ⑤ Suspected androgen secreting adrenal or ovarian tumor.

2. Use of hormonal or other medication including Chinese Herbal prescriptions which may affect the outcome the last 2 months.

3. Receiving acupuncture in the past 2 months.

4. Within 6 weeks pregnancy.

5. Post-abortion or postpartum within the past 6 weeks.

6. Breastfeeding within the last 4 months.

7. Not willing to give written consent to the study.

8. Having a bariatric surgery procedure within the past 12 months or being in a period of acute weight loss.

9. Additional exclusion criteria including:

• Patients on oral contraceptives, depot progestins, or hormonal implants (including Implanon). A two month washout period will be required prior to screening for patients on these agents. Longer washouts may be necessary for certain depot contraceptive forms or implants, especially where the implants are still in place. A one-month washout will be required for patients on oral cyclic progestins.

• Heart disease ③ Patients with a history of, or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma.

• Patients enrolled into other studies that require medications. ⑤ Patients taking longer than a one month break during the protocol should not be enrolled.