search
Back to results

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

Primary Purpose

Polycystic Ovary Syndrome, Insulin Resistance

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Auricular acupoints acupressure
Sham auricular acupoints acupressure
Sponsored by
Heilongjiang University of Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic Ovary Syndrome, Insulin Resistance

Eligibility Criteria

15 Years - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • First Affiliated Hospital, Heilongjiang University of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Auricular acupoints acupressure

Sham auricular acupoints acupressure

Arm Description

Outcomes

Primary Outcome Measures

Homeostasis model assessment-insulin resistance (HOMA-IR)
HOMA-IR was calculated as [Plasma glucose (GLU,mmol/L)* serum insulin (mIU/L)] / 22.5.

Secondary Outcome Measures

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

Full Information

First Posted
May 23, 2018
Last Updated
December 23, 2019
Sponsor
Heilongjiang University of Chinese Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT03546595
Brief Title
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heilongjiang University of Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Insulin Resistance
Keywords
Polycystic Ovary Syndrome, Insulin Resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Auricular acupoints acupressure
Arm Type
Experimental
Arm Title
Sham auricular acupoints acupressure
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
Auricular acupoints acupressure
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham auricular acupoints acupressure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Homeostasis model assessment-insulin resistance (HOMA-IR)
Description
HOMA-IR was calculated as [Plasma glucose (GLU,mmol/L)* serum insulin (mIU/L)] / 22.5.
Time Frame
3 month
Secondary Outcome Measure Information:
Title
Testosterone(T)
Time Frame
3 month
Title
Androstadienedione (AND)
Time Frame
3 month
Title
Sex hormone-binding globulin (SHBG)
Time Frame
3 month
Title
Dehydroepiandrosterone sulfate (DHEAS)
Time Frame
3 month
Title
Follicle stimulating hormone (FSH)
Time Frame
3 month
Title
Luteinizing hormone (LH)
Time Frame
3 month
Title
Estradiol (E2)
Time Frame
3 month
Title
Weight
Time Frame
3 month
Title
Waist/hip circumference
Time Frame
3 month
Title
BMI
Time Frame
3 month
Title
FG score
Time Frame
3 month
Title
Acne
Time Frame
3 month
Title
Short-Form Health Survey (SF-36)
Time Frame
3 month
Title
The Chinese Quality of Life questionnaire (ChQoL)
Time Frame
3 month
Title
Health-related quality of life questionnaire for polycystic ovary syndrome (PCOSQ)
Time Frame
3 month

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150040
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31142530
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.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs