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

Study Overview
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Brief Summary
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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.

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

Conditions
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Polycystic Ovary Syndrome, Insulin Resistance

Intervention / Treatment
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* Other: Auricular acupoints acupressure
* Other: Sham auricular acupoints acupressure


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Auricular acupoints acupressure<br> | Other: Auricular acupoints acupressure<br>* 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.<br>|
| Sham Comparator: Sham auricular acupoints acupressure<br> | Other: Sham auricular acupoints acupressure<br>* 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.<br>|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polycystic Ovary Syndrome, Insulin Resistance