Polycystic Ovary SyndromeNCT03546595
Auricular Acupressure (AA) For Insulin Resistance in Women With Polycystic Ovary Syndrome
A study testing Auricular acupoints acupressure in people with Polycystic Ovary Syndrome and Insulin Resistance, run by Heilongjiang University of Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 15 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Insulin Resistance
- What is being tested?
- Auricular acupoints acupressure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital, Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, 150040
About this study
Official title: Effect of Auricular Points Acupressure for Overweight/Obese Women With Polycystic Ovary Syndrome.
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
- Being tested
- Auricular acupoints acupressure, Sham auricular acupoints acupressure
- Keywords
- Polycystic Ovary Syndrome, Insulin Resistance
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular acupoints acupressureOther
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 acupressureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Auricular acupoints acupressure | Experimental | Not described Receives: Other: Auricular acupoints acupressure |
| Sham auricular acupoints acupressure | Sham comparator | Not described Receives: Other: Sham auricular acupoints acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Homeostasis model assessment-insulin resistance (HOMA-IR)
HOMA-IR was calculated as [Plasma glucose (GLU,mmol/L)* serum insulin (mIU/L)] / 22.5.
Measured: 3 month
Secondary outcomes (15)
Testosterone(T)
Measured: 3 month
Androstadienedione (AND)
Measured: 3 month
Sex hormone-binding globulin (SHBG)
Measured: 3 month
Dehydroepiandrosterone sulfate (DHEAS)
Measured: 3 month
Follicle stimulating hormone (FSH)
Measured: 3 month
Luteinizing hormone (LH)
Measured: 3 month
Estradiol (E2)
Measured: 3 month
Weight
Measured: 3 month
Waist/hip circumference
Measured: 3 month
BMI
Measured: 3 month
FG score
Measured: 3 month
Acne
Measured: 3 month
Short-Form Health Survey (SF-36)
Measured: 3 month
The Chinese Quality of Life questionnaire (ChQoL)
Measured: 3 month
Health-related quality of life questionnaire for polycystic ovary syndrome (PCOSQ)
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 Jul 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heilongjiang University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Li, Heilongjiang University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546595
- Sponsor's protocol ID
- AA for IR-PCOS
- Status last verified
- Dec 2019
- First submitted
- 23 May 2018
- Last updated
- 26 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31142530
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Auricular Points Acupressure for Overweight/Obese Women With Polycystic Ovary Syndrome.
- ClinicalTrials.gov ID
- NCT03546595
- Acronym / sponsor ID
- AA for IR-PCOS
- Conditions
- Polycystic Ovary Syndrome, Insulin Resistance
- Keywords
- Polycystic Ovary Syndrome, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Heilongjiang University of Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auricular acupoints acupressure | Experimental | Other: Auricular acupoints acupressure |
| Sham auricular acupoints acupressure | Sham comparator | Other: Sham auricular acupoints acupressure |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular acupoints acupressureThe 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. | Other | Auricular acupoints acupressure |
| Sham auricular acupoints acupressureThe 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. | Other | Sham auricular acupoints acupressure |
Primary outcome
Homeostasis model assessment-insulin resistance (HOMA-IR)
Time frame: 3 month
HOMA-IR was calculated as [Plasma glucose (GLU,mmol/L)* serum insulin (mIU/L)] / 22.5.
15 secondary outcomes
Testosterone(T)
Time frame: 3 month
Androstadienedione (AND)
Time frame: 3 month
Sex hormone-binding globulin (SHBG)
Time frame: 3 month
Dehydroepiandrosterone sulfate (DHEAS)
Time frame: 3 month
Follicle stimulating hormone (FSH)
Time frame: 3 month
Luteinizing hormone (LH)
Time frame: 3 month
Estradiol (E2)
Time frame: 3 month
Weight
Time frame: 3 month
Waist/hip circumference
Time frame: 3 month
BMI
Time frame: 3 month
FG score
Time frame: 3 month
Acne
Time frame: 3 month
Short-Form Health Survey (SF-36)
Time frame: 3 month
The Chinese Quality of Life questionnaire (ChQoL)
Time frame: 3 month
Health-related quality of life questionnaire for polycystic ovary syndrome (PCOSQ)
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2019.
- Derived from this study: PubMed 31142530Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auricular acupoints acupressure in people with Polycystic Ovary Syndrome and Insulin Resistance, run by Heilongjiang University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Homeostasis model assessment-insulin resistance (HOMA-IR) (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03546595, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2019.