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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 23, 2018
First Posted Date  ICMJE June 6, 2018
Last Update Posted Date December 26, 2019
Actual Study Start Date  ICMJE July 1, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2018)
HOMA-IR [ Time Frame: 3 month ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • Testosterone(T) [ Time Frame: 3 month ]
  • Androstadienedione (AND) [ Time Frame: 3 month ]
  • Sex hormone-binding globulin (SHBG) [ Time Frame: 3 month ]
  • Dehydroepiandrosterone sulfate (DHEAS) [ Time Frame: 3 month ]
  • Follicle stimulating hormone (FSH) [ Time Frame: 3 month ]
  • Luteinizing hormone (LH) [ Time Frame: 3 month ]
  • Estradiol (E2) [ Time Frame: 3 month ]
  • Weight [ Time Frame: 3 month ]
  • Waist/hip circumference [ Time Frame: 3 month ]
  • BMI [ Time Frame: 3 month ]
  • FG score [ Time Frame: 3 month ]
  • Acne [ Time Frame: 3 month ]
  • Short-Form Health Survey (SF-36) [ Time Frame: 3 month ]
  • The Chinese Quality of Life questionnaire (ChQoL) [ Time Frame: 3 month ]
  • Health-related quality of life questionnaire for polycystic ovary syndrome (PCOSQ) [ Time Frame: 3 month ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2018)
  • Follicle stimulating hormone (FSH) [ Time Frame: 3 month ]
  • Luteinizing hormone (LH) [ Time Frame: 3 month ]
  • Testosterone (T) [ Time Frame: 3 month ]
  • Waist/hip ratio [ Time Frame: 3 month ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Auricular Acupressure (AA) For Insulin Resistance in Women With Polycystic Ovary Syndrome
Official Title  ICMJE Effect of Auricular Points Acupressure for Overweight/Obese Women With Polycystic Ovary Syndrome.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Polycystic Ovary Syndrome
  • Insulin Resistance
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Auricular acupoints acupressure
    Intervention: Other: Auricular acupoints acupressure
  • Sham Comparator: Sham auricular acupoints acupressure
    Intervention: Other: Sham auricular acupoints acupressure
Publications * Li Y, Hou L, Wang Y, Xie L, Zhang M, Pan Z, Li Y, Ding Y, Sun M, Qu Y, Liu S. Auricular points acupressure for insulin resistance in overweight/obese women with polycystic ovary syndrome: protocol for a randomised controlled pilot trial. BMJ Open. 2019 May 28;9(5):e027498. doi: 10.1136/bmjopen-2018-027498.

*   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
Actual Enrollment  ICMJE
 (submitted: October 15, 2018)
60
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2018)
100
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 40 Years   (Child, 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 NCT03546595
Other Study ID Numbers  ICMJE AA for IR-PCOS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Yan Li, Heilongjiang University of Chinese Medicine
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Heilongjiang University of Chinese Medicine
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Heilongjiang University of Chinese Medicine
Verification Date December 2019

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