The Effect of Acupuncture on Insulin Sensitivity of Women With Polycystic Ovary Syndrome and Insulin Resistance: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 342
- 试验地点
- 1
- 主要终点
- Changes of HOMA-IR
研究概览
简要总结
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.
详细描述
1.1 Study design This is a randomized double blind controlled. 1.2 Subject selection and exclusion Women with PCOS and IR will be recruited from the Department of Traditional Chinese Medicine in the first affiliated hospital of Guangzhou Medical University, Xuzhou maternity & child health hospital, Liwan hospital of traditional Chinese medicine, and Hexian memorial affiliated hospital of Southern Medical University if they meet the inclusion criteria and do not have any exclusion criteria. Eligible subjects will be approached and sign the consent form after detailed explanation of the study design and comprehensive counseling.
1.3 Screening visit Women will be screened in the morning after an overnight 12 hour fast. Detailed information about the study design will be given.
1.3.1 Sign informed consent Informed consent will be signed after detailed counseling. 1.3.2 Perform physical examination Perform complete physical examination including height, weight, hip, and waist measurement. Height and weight will be recorded to the nearest 0.1 cm and 0.1 kg respectively. Waist and hip circumference will be recorded to the nearest 1 cm. And assessment of hirsutism by FG, acne standard acne lesion counts, and pelvic exam.
1.3.3 Perform transvaginal ultrasound of ovaries Ovaries, including the ovarian size in three dimensions, the size of the largest ovarian follicle/cyst and size of every follicle with a mean diameter greater than 10 mm, and total antral follicle count (small follicles with mean diameter < 10 mm) of each ovary will be obtained through transvaginal ultrasound.
1.3.4 Check urine pregnancy test 1.3.5 Fasting blood samples to exclude other endocrine disorders Fasting (at least 4 h) blood samples will be taken to exclude any endocrine disorders:F-glucose, F-insulin, Hba1C (>7%), C-peptide, TSH (< 0.2 mIU/mL or >5.5 mIU/mL), T3 (<1.4 nmol/L or >2.2nmol/L), and free T4 (<10pmol/L or >23pmol/L).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chinese women aged from 18 to 40 years.
- •BMI ≥18.5kg/m
- •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.
- •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.
- •No immediate fertility wish and willingness to use barrier methods to contraception for one year.
- •Willingness to sign the consent form.
排除标准
- •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.
- •Use of hormonal or other medication including Chinese Herbal prescriptions which may affect the outcome the last 2 months.
- •Receiving acupuncture in the past 2 months.
- •Within 6 weeks pregnancy.
- •Post-abortion or postpartum within the past 6 weeks.
- •Breastfeeding within the last 4 months.
- •Not willing to give written consent to the study.
- •Having a bariatric surgery procedure within the past 12 months or being in a period of acute weight loss.
- •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.
研究组 & 干预措施
true acupuncture + placebo metformin
True acupuncture and placebo metformin will be started 2 days after the baseline visit including OGTT. All subjects will be asked to use a barrier method for contraception.
True acupuncture treatment will be given three times per week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 4 month.
Placebo metformin will be given at 0.5g/times, 3 times one day and for 4 month.
干预措施: true acupuncture (Other)
true acupuncture + placebo metformin
True acupuncture and placebo metformin will be started 2 days after the baseline visit including OGTT. All subjects will be asked to use a barrier method for contraception.
True acupuncture treatment will be given three times per week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 4 month.
Placebo metformin will be given at 0.5g/times, 3 times one day and for 4 month.
干预措施: Placebo metformin (Drug)
sham acupuncture + placebo metformin
Sham acupuncture and placebo metformin will be started 2 days after the baseline visit including OGTT. All subjects will be asked to use a barrier method for contraception.
Sham acupuncture treatment will be given three times per week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 4 month. Placement of needles is unlikely to affect ovulation and IR in women with PCOS.
Placebo metformin will be given at 0.5g/times, 3 times one day and for 4 month.
干预措施: sham acupuncture (Other)
sham acupuncture + placebo metformin
Sham acupuncture and placebo metformin will be started 2 days after the baseline visit including OGTT. All subjects will be asked to use a barrier method for contraception.
Sham acupuncture treatment will be given three times per week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 4 month. Placement of needles is unlikely to affect ovulation and IR in women with PCOS.
Placebo metformin will be given at 0.5g/times, 3 times one day and for 4 month.
干预措施: Placebo metformin (Drug)
sham acupuncture + metformin
Sham acupuncture and metformin will be started 2 days after the baseline visit including OGTT. All subjects will be asked to use a barrier method for contraception.
Sham acupuncture treatment will be given three times per week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 4 month.Placement of needles is unlikely to affect ovulation and IR in women with PCOS.
Metformin will be given at 0.5g/times, 3 times one day and for 4 month.
干预措施: sham acupuncture (Other)
sham acupuncture + metformin
Sham acupuncture and metformin will be started 2 days after the baseline visit including OGTT. All subjects will be asked to use a barrier method for contraception.
Sham acupuncture treatment will be given three times per week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 4 month.Placement of needles is unlikely to affect ovulation and IR in women with PCOS.
Metformin will be given at 0.5g/times, 3 times one day and for 4 month.
干预措施: metformin (Drug)
结局指标
主要结局
Changes of HOMA-IR
时间窗: Change from Baseline Systolic Blood Pressure at 4 months and 7 months
次要结局
- AUCglu(4 months and 7 months)
- HOMA-B(4 months and 7 months)
- Menstrual frequency(4 months and 7 months)
- Body composition（a composite）(4 months and 7 months)
- Metabolic profile（a composite）(4 months and 7 months)
- Hormonal profile（a composite）(4 months and 7 months)
- Questionnaires（a composite）(4 months and 7 months)
- Side effect profile(4 months and 7 months)
- Expectation and credibility of treatment（questionnaire, 6 questions，4grades，0-24scores)(1 week and 4 months)
- AUCins(4 months and 7 months)
- Ovulation rate(4 months and 7 months)
研究者
Hongxia Ma
Professor
The First Affiliated Hospital of Guangzhou Medical University