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

Insulin Resistance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03546595
• Other study ID #: AA for IR-PCOS
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: December 2019
• Source: Heilongjiang University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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 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.

Locations

Country	Name	City	State
China	First Affiliated Hospital, Heilongjiang University of Chinese Medicine	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

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