Insulin Resistance, Polycystic Ovary Syndrome
Conditions
Keywords
Polycystic Ovary Syndrome, Insulin Resistance
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.
Interventions
OTHERAuricular 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.
OTHERSham 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.
Sponsors
Heilongjiang University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 40 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Testosterone(T) | 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 |
| Waist/hip circumference | 3 month |
Countries
China
Outcome results
None listed