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

Sponsor
Heilongjiang University of Chinese Medicine (Other)
Overall Status
Unknown status
CT.gov ID
NCT03546595
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
30
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Auricular acupoints acupressure
  • Other: Sham auricular acupoints acupressure
 N/A

Study Design

Study Type:
Interventional
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 :
Jul 1, 2018
Anticipated Primary Completion Date :
Dec 31, 2019
Anticipated Study Completion Date :
Dec 31, 2020

Arms and Interventions

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

Primary Outcome Measures

  1. Homeostasis model assessment-insulin resistance (HOMA-IR) [3 month]

    HOMA-IR was calculated as [Plasma glucose (GLU,mmol/L)* serum insulin (mIU/L)] / 22.5.

Secondary Outcome Measures

  1. Testosterone(T) [3 month]

  2. Androstadienedione (AND) [3 month]

  3. Sex hormone-binding globulin (SHBG) [3 month]

  4. Dehydroepiandrosterone sulfate (DHEAS) [3 month]

  5. Follicle stimulating hormone (FSH) [3 month]

  6. Luteinizing hormone (LH) [3 month]

  7. Estradiol (E2) [3 month]

  8. Weight [3 month]

  9. Waist/hip circumference [3 month]

  10. BMI [3 month]

  11. FG score [3 month]

  12. Acne [3 month]

  13. Short-Form Health Survey (SF-36) [3 month]

  14. The Chinese Quality of Life questionnaire (ChQoL) [3 month]

  15. Health-related quality of life questionnaire for polycystic ovary syndrome (PCOSQ) [3 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 First Affiliated Hospital, Heilongjiang University of Chinese Medicine Harbin Heilongjiang China 150040

Sponsors and Collaborators

  • Heilongjiang University of Chinese Medicine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jun 6, 2018
Last Update Posted:
Dec 26, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yan Li, Associate chief physician, Heilongjiang University of Chinese Medicine
Polycystic Ovary Syndrome
Insulin Resistance
Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Insulin Resistance
Syndrome

Study Results

No Results Posted as of Dec 26, 2019