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

NCT03546595 | Unknown

• 1 other identifier: AA for IR-PCOS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Keywords

Polycystic Ovary Syndrome; Insulin Resistance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• 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

Study Arms (2)

Auricular acupoints acupressure

EXPERIMENTAL

Other: Auricular acupoints acupressure

Sham auricular acupoints acupressure

SHAM COMPARATOR

Other: Sham auricular acupoints acupressure

Interventions

Auricular acupoints acupressure OTHER

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.

Auricular acupoints acupressure

Sham auricular acupoints acupressure OTHER

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.

Sham auricular acupoints acupressure

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women aged between 15 and 40 years.
• Diagnosis of PCOS according to the modified Rotterdam criteria.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heilongjiang University of Chinese Medicine: lead

Study Sites (1)

First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, 150040, China

Location

Related Publications (1)

• 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.

  PMID: 31142530 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Insulin Resistance

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 6, 2018
• Study Start: July 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2020
• Last Updated: December 26, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)