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The Effect of Acupuncture on Insulin Sensitivity Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT02026323
Recruitment Status : Unknown
Verified September 2014 by Yanhua-Zheng, The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Enrolling by invitation
First Posted : January 1, 2014
Last Update Posted : September 8, 2014
Sponsor:
Information provided by (Responsible Party):
Yanhua-Zheng, The First Affiliated Hospital of Guangzhou Medical University

Tracking Information
First Submitted Date  ICMJE December 27, 2013
First Posted Date  ICMJE January 1, 2014
Last Update Posted Date September 8, 2014
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 31, 2013)
HOMA-IR [ Time Frame: baseline,treat for 3 and 6 month ,3 or 6 month follow-up ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2014)
  • FSH [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
    Determine FSH by electrogenerated chemiluminescence.
  • LH [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • Androgen [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • Progesterone [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • Prolactin [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • Estradiol [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • dehydroepiandrosterone(sodium)sulfate [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • sex hormone binding globulin [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • c-peptide [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • Apoa1 [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • ApoB [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • TC [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • TG [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • glycosylated hemoglobin [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • 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).
  • Transvaginal ultrasound [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 31, 2013)
  • FSH [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
    Determine FSH by electrogenerated chemiluminescence.
  • LH [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • Androgen [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • Progesterone [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • Prolactin [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • Estradiol [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • dehydroepiandrosterone(sodium)sulfate [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • sex hormone binding globulin [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • hs-CRP [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • Apoa1 [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • ApoB [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • TC [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • TG [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • glycosylated hemoglobin [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
  • 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).
  • Transvaginal ultrasound [ Time Frame: baseline,up to 6 month,the follow-up of 3 or 6 month ]
Current Other Pre-specified Outcome Measures
 (submitted: December 31, 2013)
Body composition(weight,height,waist circumference,hip circumference) [ Time Frame: baseline,every month in treatment,the follow-up of 3 or 6 month ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Effect of Acupuncture on Insulin Sensitivity Polycystic Ovary Syndrome
Official Title  ICMJE Effect of Acupuncture on Insulin Sensitivity in Women With Polycystic Ovary Syndrome and Insulin Resistance: Study Protocol of a Prospective Observational Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Polycystic Ovary Syndrome
  • Insulin Resistance
Intervention  ICMJE Other: acupuncture
acupuncture
Study Arms  ICMJE
  • Experimental: acupuncture
    "Normal weight" 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.
    Intervention: Other: acupuncture
  • Experimental: acupuncture 2
    "Over weight or 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.
    Intervention: Other: acupuncture
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 31, 2013)
112
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2015
Estimated Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02026323
Other Study ID Numbers  ICMJE PCOSAir
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Yanhua-Zheng, The First Affiliated Hospital of Guangzhou Medical University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The First Affiliated Hospital of Guangzhou Medical University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Hongxia HX Ma, Dorctor Study sponsor
PRS Account The First Affiliated Hospital of Guangzhou Medical University
Verification Date September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP