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

Effect of Auricular Points Acupressure for Overweight/Obese Women With Polycystic Ovary Syndrome.

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.

Study Overview

• Status: Unknown
• Conditions: Polycystic Ovary Syndrome; Insulin Resistance
• Intervention / Treatment: Other: Auricular acupoints acupressure; Other: Sham auricular acupoints acupressure

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150040
      • First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 36 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Testosterone(T)	3 month
Androstadienedione (AND)	3 month
Sex hormone-binding globulin (SHBG)	3 month
Dehydroepiandrosterone sulfate (DHEAS)	3 month
Follicle stimulating hormone (FSH)	3 month
Luteinizing hormone (LH)	3 month
Estradiol (E2)	3 month
Weight	3 month
Waist/hip circumference	3 month
BMI	3 month
FG score	3 month
Acne	3 month
Short-Form Health Survey (SF-36)	3 month
The Chinese Quality of Life questionnaire (ChQoL)	3 month
Health-related quality of life questionnaire for polycystic ovary syndrome (PCOSQ)	3 month

Collaborators and Investigators

• Sponsor: Heilongjiang University of Chinese Medicine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): December 26, 2019
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Insulin Resistance; Polycystic Ovary Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Hyperinsulinism; Polycystic Ovary Syndrome; Syndrome; Insulin Resistance
• Other Study ID Numbers: AA for IR-PCOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No