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Auricular Acupressure (AA) For Insulin Resistance in Women With Polycystic Ovary Syndrome

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ClinicalTrials.gov Identifier: NCT03546595
Recruitment Status : Unknown
Verified December 2019 by Yan Li, Heilongjiang University of Chinese Medicine.
Recruitment status was:  Active, not recruiting
First Posted : June 6, 2018
Last Update Posted : December 26, 2019
Sponsor:
Information provided by (Responsible Party):
Yan Li, Heilongjiang University of Chinese Medicine

Study Description
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Brief Summary:

The present trial is a pilot study to investigate the effect of auricular acupressure on insulin resistance in women with PCOS.A total of 100 subjects will be enrolled into this study and will be randomized into two groups.

Auricular acupressure or sham auricular acupressure will be treated for three months. The primary outcome is the whole body insulin action assessed with HOMA-IR.


Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Insulin Resistance Other: Auricular acupoints acupressure Other: Sham auricular acupoints acupressure Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Auricular Points Acupressure for Overweight/Obese Women With Polycystic Ovary Syndrome.
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Auricular acupoints acupressure Other: Auricular acupoints acupressure
The magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were asked to massage the points for 5 minutes, 30 minutes before three meals and sleep.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear.
Sham Comparator: Sham auricular acupoints acupressure Other: Sham auricular acupoints acupressure
The magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were not asked to massage the points.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear.


Outcome Measures
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Primary Outcome Measures :
  1. Homeostasis model assessment-insulin resistance (HOMA-IR) [ Time Frame: 3 month ]
    HOMA-IR was calculated as [Plasma glucose (GLU,mmol/L)* serum insulin (mIU/L)] / 22.5.


Secondary Outcome Measures :
  1. Testosterone(T) [ Time Frame: 3 month ]
  2. Androstadienedione (AND) [ Time Frame: 3 month ]
  3. Sex hormone-binding globulin (SHBG) [ Time Frame: 3 month ]
  4. Dehydroepiandrosterone sulfate (DHEAS) [ Time Frame: 3 month ]
  5. Follicle stimulating hormone (FSH) [ Time Frame: 3 month ]
  6. Luteinizing hormone (LH) [ Time Frame: 3 month ]
  7. Estradiol (E2) [ Time Frame: 3 month ]
  8. Weight [ Time Frame: 3 month ]
  9. Waist/hip circumference [ Time Frame: 3 month ]
  10. BMI [ Time Frame: 3 month ]
  11. FG score [ Time Frame: 3 month ]
  12. Acne [ Time Frame: 3 month ]
  13. Short-Form Health Survey (SF-36) [ Time Frame: 3 month ]
  14. The Chinese Quality of Life questionnaire (ChQoL) [ Time Frame: 3 month ]
  15. Health-related quality of life questionnaire for polycystic ovary syndrome (PCOSQ) [ Time Frame: 3 month ]

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women aged between 15 and 40 years.
  • Diagnosis of PCOS according to the modified Rotterdam criteria.
  • 2 years after menarche.
  • Body mass index (BMI) equal to or greater than 23 kg/m2.
  • IR is defined by the homeostaticmodel 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.
  • With no desire of children within 3 months.

Exclusion Criteria:

  • Administration of other medications known to affect reproductive function or metabolism within the past three months, including oral contraceptives, Gonadotropin-releasing hormone (GnRH) agonists and antagonists, anti androgens, gonadotropins, anti-obesity drugs, Chinese herbal medicines, anti diabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, and calcium channel blockers.
  • Patients with other endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, uncorrected thyroid disease, suspected Cushing's syndrome.
  • Patients with known severe organ dysfunction or mental illness.
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): NCT03546595


Locations
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China, Heilongjiang
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, China, 150040
Sponsors and Collaborators
Heilongjiang University of Chinese Medicine
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yan Li, Associate chief physician, Heilongjiang University of Chinese Medicine
ClinicalTrials.gov Identifier: NCT03546595    
Other Study ID Numbers: AA for IR-PCOS
First Posted: June 6, 2018    Key Record Dates
Last Update Posted: December 26, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yan Li, Heilongjiang University of Chinese Medicine:
Polycystic Ovary Syndrome
Insulin Resistance
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