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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Insulin Resistance Other: acupuncture Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2014
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : May 2015

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Arms and Interventions
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Arm Intervention/treatment
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.
 Other: acupuncture
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.
 Other: acupuncture
acupuncture


Outcome Measures
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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. c-peptide [ 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   Female
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02026323


Locations
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China, Guangdong
The first affiliated hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510120
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Investigators
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Study Chair: Hongxia HX Ma, Dorctor Study sponsor
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yanhua-Zheng, Attending physician, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT02026323    
Other Study ID Numbers: PCOSAir
First Posted: January 1, 2014    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Insulin Resistance
Syndrome
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases