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

• ClinicalTrials.gov Identifier: NCT03546595
• Recruitment Status: Unknown
• First Posted: June 6, 2018
• Last Update Posted: December 26, 2019
• Sponsor: Heilongjiang University of Chinese Medicine
• Information provided by (Responsible Party): Yan Li, Heilongjiang University of Chinese Medicine

Tracking Information

• First Submitted Date: May 23, 2018
• First Posted Date: June 6, 2018
• Last Update Posted Date: December 26, 2019
• Actual Study Start Date: July 1, 2018
• Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: May 23, 2018): HOMA-IR [ Time Frame: 3 month ]

Current Secondary Outcome Measures (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 (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: Auricular Acupressure (AA) For Insulin Resistance in Women With Polycystic Ovary Syndrome
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Polycystic Ovary Syndrome
• Insulin Resistance

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: October 15, 2018): 60
• Original Estimated Enrollment (submitted: May 23, 2018): 100
• Estimated Study Completion Date: December 31, 2020
• Estimated Primary Completion Date: December 31, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 15 Years to 40 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03546595
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Yan Li, Heilongjiang University of Chinese Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: Heilongjiang University of Chinese Medicine
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Heilongjiang University of Chinese Medicine
• Verification Date: December 2019