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History of Changes for Study: NCT02026323
The Effect of Acupuncture on Insulin Sensitivity Polycystic Ovary Syndrome
Latest version (submitted September 5, 2014) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 December 31, 2013 None (earliest Version on record)
2 January 17, 2014 Recruitment Status, Study Status and Contacts/Locations
3 September 5, 2014 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures, Arms and Interventions and Study Identification
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Study NCT02026323
Submitted Date:  December 31, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: PCOSAir
Brief Title: The Effect of Acupuncture on Insulin Sensitivity Polycystic Ovary Syndrome
Official Title: The Effect of Acupuncture on Insulin Sensitivity in Insulin Resistance Women With Polycystic Ovary Syndrome A Pilot Study
Secondary IDs:
Open or close this module Study Status
Record Verification: December 2013
Overall Status: Not yet recruiting
Study Start: February 2014
Primary Completion: October 2014 [Anticipated]
Study Completion: May 2015 [Anticipated]
First Submitted: December 27, 2013
First Submitted that
Met QC Criteria:
December 31, 2013
First Posted: January 1, 2014 [Estimate]
Last Update Submitted that
Met QC Criteria:
December 31, 2013
Last Update Posted: January 1, 2014 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: The First Affiliated Hospital of Guangzhou Medical University
Responsible Party: Principal Investigator
Investigator: Yanhua-Zheng
Official Title: Attending physician
Affiliation: The First Affiliated Hospital of Guangzhou Medical University
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Polycystic Ovary Syndrome
Insulin Resistance
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 112 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: acupuncture
"No obese" group,the PCOS women with insulin resistance who are normal weight( BMI=18.5-23Kg/m2).The acupuncture treatment will last for six months, 3 times per week, 30 minutes per treatment.
acupuncture
acupuncture
Experimental: acupuncture 2
"Obese" group ,the PCOS women with insulin resistance who are overweight or obese: BMI >23 Kg/m2.The acupuncture treatment will last for six months, 3 times per week, 30 minutes per treatment.
acupuncture
acupuncture
Open or close this module Outcome Measures
Primary Outcome Measures:
1. HOMA-IR
[ Time Frame: baseline,treat for 3 and 6 month ,3 or 6 month follow-up ]

Secondary Outcome Measures:
1. FSH
[ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]

Determine FSH by electrogenerated chemiluminescence.
2. LH
[ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]

3. Androgen
[ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]

4. Progesterone
[ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]

5. Prolactin
[ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]

6. Estradiol
[ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]

7. dehydroepiandrosterone(sodium)sulfate
[ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]

8. sex hormone binding globulin
[ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]

9. hs-CRP
[ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]

10. Apoa1
[ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]

11. ApoB
[ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]

12. TC
[ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]

13. TG
[ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]

14. glycosylated hemoglobin
[ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]

15. Questionnaire investigation
[ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]

Health related quality of life, affective symptoms and personality: Will be determined by short form-36 (SF36), polycystic ovary syndrome questionnaire (PCOSQ),(generic and diagnosis-specific HRQL questionnaire),and the Chinese Quality of Life (ChQOL) ,and symptoms of anxiety and depression assessed by the Zung Self-Rating Anxiety Scale (Zung SAS) and Zung Self-Rating Depression Scale (Zung SDS).
16. Transvaginal ultrasound
[ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]

Other Outcome Measures:
1. Body composition(weight,height,waist circumference,hip circumference)
[ Time Frame: baseline,every month in treatment,the follow-up of 3 or 6 month ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 49 Years
Sex: Female
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Hongxia-Ma HX Ma, Dorctor
Telephone: 18928868335
Email: doctorhongxia@126.com
Central Contact Backup: Yanhua-Zheng YH Zheng, Master
Telephone: 13710788569
Study Officials: Hongxia HX Ma, Dorctor
Study Chair
Study sponsor
Locations: China, Guangdong
The first affiliated hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
Contact:Contact: Hongxia HX Ma, Dorctor 18928868335
Contact:Principal Investigator: Yanhua YH Zheng, Master
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations: [Study Results] 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. PubMed 23676106
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