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Polycystic Ovary SyndromeNCT02026323

The Effect of Acupuncture on Insulin Sensitivity Polycystic Ovary Syndrome

A study testing acupuncture in people with Polycystic Ovary Syndrome and Insulin Resistance, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Hyperinsulinemia and insulin resistance play a key role in the pathogenesis of polycystic ovary syndrome (PCOS). Insulin resistance is significantly associated with the long-term risks of metabolic syndrome and cardiovascular disease. Read more about this study

Who is it for?
Ages 18 to 49 years, women only
Conditions the study is for
Polycystic Ovary Syndrome, Insulin Resistance
What is being tested?
acupuncture
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
1 siteChina
Study dates
Jan 2014to May 2015
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 18 to 49 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age ≥ 18 years.
  • BMI ≥18.5Kg/m2
  • Confirmed diagnosis of PCOS according to the Rotterdam criteria: Oligo-, amenorrhea (less than 8 cycles per year) or/clinical or biochemical hyperandrogenism and/or polycystic ovarian morphology.
  • IR defined by the homeostatic model assessment (HOMA-IR: fasting insulin x fasting glucose/22.5) and 2.14 will be used as the cut off 33.
  • No desire of children and using barrier methods of contraception for 1 year.
  • Willing to sign the consent form

Who cannot join

  • With other endocrine disorders such as hyperprolactinemia (defined as two prolactin levels at least one week apart 25 ng/mL or greater or as determined by local normative values), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone <3nmol/L), and androgen secreting tumors.
  • Patients with FSH levels > 15 mIU/mL. A normal level within the last year is adequate for entry.
  • Patients with uncorrected thyroid disease (defined as TSH < 0.2 mIU/mL or >5.5 mIU/mL). A normal level within the last year is adequate for entry.
  • Patients diagnosed with Type I diabetes, or Type I and Type II patients who receiving antidiabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas likely to confound the effects of study medication; patients currently receiving metformin for a diagnosis of Type I or Type II diabetes or for PCOS are also specifically excluded.
  • Patients with suspected Cushing's syndrome.
  • Use of hormonal or other medication including Chinese Herbal prescriptions which may affect the outcome at least in the past 3 months.
Show all 13Show fewer
  • Pregnancy within the last 6 weeks.
  • Post-abortion or postpartum within last 6 weeks.
  • Breastfeeding within the last 6 months.
  • Patients received Acupuncture treatment related to PCOS within the last 2 months.
  • Patients who have undergone a bariatric surgery procedure in the recent past (<12 months) and are in a period of acute weight loss.
  • Patients with known congenital adrenal hyperplasia.
  • Not willing to give written consent to the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The first affiliated hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

Other trials in China

About this study

Official title: Effect of Acupuncture on Insulin Sensitivity in Women With Polycystic Ovary Syndrome and Insulin Resistance: Study Protocol of a Prospective Observational Study

Hyperinsulinemia and insulin resistance play a key role in the pathogenesis of polycystic ovary syndrome (PCOS). Insulin resistance is significantly associated with the long-term risks of metabolic syndrome and cardiovascular disease. Acupuncture with electrical stimulation has in rats with dihydrotestosterone (DHT)-induced PCOS been shown to improve insulin sensitivity. Whether these findings can be translated into women with PCOS has not been investigated. Therefore, this study aims to evaluate whether acupuncture improves insulin sensitivity, ovulation rate and quality of life in women with PCOS. Our hypothesis is that acupuncture with combined manual and low-frequency electrical stimulation of the needles improves insulin resistance, induces ovulation and improves quality of life.

Read the detailed description

This is a prospective observational study. A total of 112 women with PCOS and insulin resistance will be recruited and randomized into two groups according to their body mass index (BMI), i.e. normal weight (BMI=18.5-23Kg/m2) group and overweight or obese (BMI > 23Kg/m2) group1. The acupuncture treatment will last for six months, 3 times per week, 30 minutes per treatment. The primary outcome is changes in insulin sensitivity from baseline to after 6 months of acupuncture treatment measured by OGTT.

Being tested
acupuncture
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.

Study groups in NCT02026323
Study groupRoleWhat they receive
acupunctureExperimental"Normal weight" group,the PCOS women with insulin resistance who are normal weight( BMI=18.5-23Kg/m2).The acupuncture treatment will last for six months, 3 times per week, 30 minutes per treatment.
Receives: Other: acupuncture
acupuncture 2Experimental"Over weight or obese" group ,the PCOS women with insulin resistance who are overweight or obese: BMI >23 Kg/m2.The acupuncture treatment will last for six months, 3 times per week, 30 minutes per treatment.
Receives: Other: acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HOMA-IR

    Measured: baseline,treat for 3 and 6 month ,3 or 6 month follow-up

Secondary outcomes (16)

  1. FSH

    Determine FSH by electrogenerated chemiluminescence.

    Measured: baseline,up to 6 month,the follow-up of 3 or 6 month

  2. LH

    Measured: baseline,up to 6 month,the follow-up of 3 or 6 month

  3. Androgen

    Measured: baseline,up to 6 month,the follow-up of 3 or 6 month

  4. Progesterone

    Measured: baseline,up to 6 month,the follow-up of 3 or 6 month

  5. Prolactin

    Measured: baseline,up to 6 month,the follow-up of 3 or 6 month

  6. Estradiol

    Measured: baseline,up to 6 month,the follow-up of 3 or 6 month

  7. dehydroepiandrosterone(sodium)sulfate

    Measured: baseline,up to 6 month,the follow-up of 3 or 6 month

  8. sex hormone binding globulin

    Measured: baseline,up to 6 month,the follow-up of 3 or 6 month

  9. c-peptide

    Measured: baseline,up to 6 month,the follow-up of 3 or 6 month

  10. Apoa1

    Measured: baseline,up to 6 month,the follow-up of 3 or 6 month

  11. ApoB

    Measured: baseline,up to 6 month,the follow-up of 3 or 6 month

  12. TC

    Measured: baseline,up to 6 month,the follow-up of 3 or 6 month

  13. TG

    Measured: baseline,up to 6 month,the follow-up of 3 or 6 month

  14. glycosylated hemoglobin

    Measured: baseline,up to 6 month,the follow-up of 3 or 6 month

  15. Questionnaire investigation

    Health related quality of life, affective symptoms and personality: Will be determined by short form-36 (SF36), polycystic ovary syndrome questionnaire (PCOSQ),(generic and diagnosis-specific HRQL questionnaire),and the Chinese Quality of Life (ChQOL) ,and symptoms of anxiety and depression assessed by the Zung Self-Rating Anxiety Scale (Zung SAS) and Zung Self-Rating Depression Scale (Zung SDS).

    Measured: baseline,up to 6 month,the follow-up of 3 or 6 month

  16. Transvaginal ultrasound

    Measured: baseline,up to 6 month,the follow-up of 3 or 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jan 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionOct 2014 (estimated)
  4. Study completionMay 2015 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02026323
Sponsor's protocol ID
PCOSAir
Status last verified
Sep 2014
First submitted
27 Dec 2013
Last updated
8 Sep 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Zheng YH, Wang XH, Lai MH, Yao H, Liu H, Ma HX. Effectiveness of abdominal acupuncture for patients with obesity-type polycystic ovary syndrome: a randomized controlled trial. J Altern Complement Med. 2013 Sep;19(9):740-5. doi: 10.1089/acm.2012.0429. Epub 2013 May 15.

    PubMed 23676106

  • Zheng Y, Stener-Victorin E, Ng EH, Li J, Wu X, Ma H. How does acupuncture affect insulin sensitivity in women with polycystic ovary syndrome and insulin resistance? Study protocol of a prospective pilot study. BMJ Open. 2015 May 3;5(4):e007757. doi: 10.1136/bmjopen-2015-007757.

    PubMed 25941189

Questions about this trial

What is this clinical trial studying?

A study testing acupuncture in people with Polycystic Ovary Syndrome and Insulin Resistance, run by The First Affiliated Hospital of Guangzhou Medical University 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 13 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 8 Sep 2014. 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. 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?

HOMA-IR (time frame: baseline,treat for 3 and 6 month ,3 or 6 month follow-up). 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 NCT02026323, which also lists 2 linked publications.

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 8 Sep 2014.

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