Clinical trial NCT03546595: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Insulin Resistance
Keywords: Polycystic Ovary Syndrome
Insulin Resistance
Lead sponsor: Heilongjiang University of Chinese Medicine
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Homeostasis model assessment-insulin resistance (HOMA-IR)
timeFrame: 3 month
Secondary outcomes:
measure: Testosterone(T)
timeFrame: 3 month
measure: Androstadienedione (AND)
timeFrame: 3 month
measure: Sex hormone-binding globulin (SHBG)
timeFrame: 3 month
measure: Dehydroepiandrosterone sulfate (DHEAS)
timeFrame: 3 month
measure: Follicle stimulating hormone (FSH)
timeFrame: 3 month
measure: Luteinizing hormone (LH)
timeFrame: 3 month
measure: Estradiol (E2)
timeFrame: 3 month
measure: Weight
timeFrame: 3 month
measure: Waist/hip circumference
timeFrame: 3 month
measure: BMI
timeFrame: 3 month
measure: FG score
timeFrame: 3 month
measure: Acne
timeFrame: 3 month
measure: Short-Form Health Survey (SF-36)
timeFrame: 3 month
measure: The Chinese Quality of Life questionnaire (ChQoL)
timeFrame: 3 month
measure: Health-related quality of life questionnaire for polycystic ovary syndrome (PCOSQ)
timeFrame: 3 month
Other outcomes:
Locations:
city: Harbin
country: China
facility: First Affiliated Hospital, Heilongjiang University of Chinese Medicine
state: Heilongjiang
Study officials:
References:
citation: 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.