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

Not Applicable

• Conditions: Polycystic Ovary Syndrome; Insulin Resistance
• Interventions: Other: Auricular acupoints acupressure; Other: Sham auricular acupoints acupressure

• Registration Number: NCT03546595
• Lead Sponsor: Heilongjiang University of Chinese Medicine

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 available

Study Timeline

• Study First Submitted: 2018-05-23
• Study First Submitted QC: 2018-05-23
• Study First Posted: 2018-06-06
• Study Start: 2018-07-01
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-23
• Last Update Posted: 2019-12-26
• Primary Completion: 2019-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Auricular acupoints acupressure	Auricular acupoints acupressure	-
Sham auricular acupoints acupressure	Sham auricular acupoints acupressure	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

First Affiliated Hospital, Heilongjiang University of Chinese Medicine; 🇨🇳 Harbin, Heilongjiang, China