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Polycystic Ovary SyndromePhase 1PCOS-AcupIRNCT01457209

Acupuncture to Treat Insulin Resistance in Women With and Without Polycystic Ovary Syndrome

A Phase 1 study testing Acupuncture in people with Polycystic Ovary Syndrome and Insulin Resistance, run by Göteborg University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The central hypothesis is that acupuncture break the vicious circle of androgen excess and reverse insulin resistance and improve health related quality of life and affective symptoms in overweight and obese women with and without Polycystic Ovary Syndrome. Read more about this study

Who is it for?
Ages 18 to 38 years, women onlyHealthy volunteers can take part
Conditions the study is for
Polycystic Ovary Syndrome, Insulin Resistance
What is being tested?
Acupuncture
How many people
42 participants
Where
1 siteSweden
Study dates
Oct 2011to Dec 2013
Phase
Phase 1
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 38 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • BMI > 25 to < 35 and
  • Clinical signs of hyperandrogenism (hirsutism or acne) and
  • At least one of the following two signs; oligo/amenorrhea and/or ultrasound-verified polycystic ovaries
  • Controls should have BMI > 25 to < 35, regular cycles with 28 days ± 2 days, no signs of hyperandrogenism.

Who cannot join

  • Age > 38 years
  • Exclusion of other endocrine disorders such as hyperprolactinemia (s-prolactin < 27µg/L), nonclassic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L), and androgen secreting tumors.
  • Autoimmune disorders, cancer, Type I diabetes and Type 2 diabetes.
  • Pharmacological treatment (cortisone, antidepressant, antidiabetic, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 wks accounts for all participants.
  • Blood pressure >160 / 100 mmHg
  • Pregnancy or breastfeeding the last 6 months
  • Acupuncture last 2 months
  • Language barrier or disabled person with reduced ability to understand information.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Institute of Neuroscienncec and Physiology

    Gothenburg, 43252

Other trials in Sweden

About this study

Official title: Effect of Acupuncture on Insulin Sensitivity in Women With and Without Polycystic Ovary Syndrome

The central hypothesis is that acupuncture break the vicious circle of androgen excess and reverse insulin resistance and improve health related quality of life and affective symptoms in overweight and obese women with and without Polycystic Ovary Syndrome.

Read the detailed description

Polycystic ovary syndrome (PCOS) is the most common endocrine and metabolic disorder in women. The main metabolic phenotype is hyperinsulinemia and insulin resistance, which are independent of body weight and worsen hyperandrogenism and ovulatory dysfunction. Pharmacological treatments are symptom oriented and usually effective but have metabolic and gastrointestinal side effects. Therefore, it is important to evaluate new nonpharmacological treatment strategies, as most women with PCOS require long-term treatment.

Hypothesis and Aims Our central hypothesis is that acupuncture break the vicious circle of androgen excess and reverse insulin resistance and improve health related quality of life and affective symptoms in overweight and obese women with and without PCOS.

The specific aim are designed to test the hypotheses that

  1. Acupuncture (acute and chronic i.e. 5 weeks treatment, 3 times per week) improves insulin sensitivity in overweight and obese women with and without PCOS
  2. Acupuncture (acute and chronic i.e. 5 weeks treatment, 3 times per week) regulate key signaling molecules and mitochondrial oxidation/biogenesis in skeletal muscle and adipose tissue in overweight and obese women with and without PCOS
  3. Acupuncture (chronic i.e. 5 weeks treatment, 3 times per week) improve health related quality of life and symptoms of anxiety and depression in overweight and obese women with and without PCOS

Time frame of the study is 5-6 weeks. No long term follow up.

Being tested
Acupuncture
Keywords
PCOS, Insulin resistance, 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.

  • AcupunctureOther

    Needle placement in abdominal muscles, in m. vastus lateralis, lower leg and hands.

    Stimulation: Manual rotation of the needles and electrical stimulation of the needles in the abdominal muscles and m. vastus lateralis will be stimulated electrically with low burst frequency Duration: 30 min Treatment: 3 times/wk during 5 weeks.

What is being measured

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

  1. Change in insulin sensitivity

    glucose disposal rate measured by euglycemic hyperinsulinemic clamp.

    Measured: Day 1 and Week 5

Secondary outcomes (4)

  1. Change in insulin signaling (muscle and adipose tissue)

    Western blot, RT-PCR

    Measured: Day 1 and Week 5

  2. Change in health related quality of life

    PCOSQ, SF36

    Measured: Day 1 and Week 5

  3. Change in symptoms of anxiety and depression

    CPRS-SA

    Measured: Day 1 and Week 5

  4. Change in circulating sex steroids, adipokines, lipids and inflammatory markers

    Mass spectrometry, ELISA

    Measured: Day 1 and Week 5

Timeline

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

  1. First posted21 Oct 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionDec 2013
  4. Study completionDec 2013

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01457209
Sponsor's protocol ID
PCOS-AcupIR
Acronym
PCOS-AcupIR
Status last verified
Jan 2014
First submitted
6 Oct 2011
Last updated
22 Jan 2014
Results posted
No
Data monitoring committee
No

Publications

  • Samad M, Ek J, Kataoka J, Lindgren E, Ohlsson C, Wernstedt Asterholm I, Stener-Victorin E, Benrick A. Hypoadiponectinemia does not enhance anxiety-like behaviour in a lean PCOS-like mouse model. Sci Rep. 2026 Sep 3;16(1):27688. doi: 10.1038/s41598-026-69143-9.

    PubMed 42693220

  • Benrick A, Pillon NJ, Nilsson E, Lindgren E, Krook A, Ling C, Stener-Victorin E. Electroacupuncture Mimics Exercise-Induced Changes in Skeletal Muscle Gene Expression in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2020 Jun 1;105(6):2027-41. doi: 10.1210/clinem/dgaa165.

    PubMed 32232327

  • Nilsson E, Benrick A, Kokosar M, Krook A, Lindgren E, Kallman T, Martis MM, Hojlund K, Ling C, Stener-Victorin E. Transcriptional and Epigenetic Changes Influencing Skeletal Muscle Metabolism in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab. 2018 Dec 1;103(12):4465-4477. doi: 10.1210/jc.2018-00935.

    PubMed 30113663

  • 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 Phase 1 study testing Acupuncture in people with Polycystic Ovary Syndrome and Insulin Resistance, run by Göteborg University at 1 site in Sweden.

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 4 inclusion and 8 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: finished, as of the sponsor's last update on 22 Jan 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 Sweden. 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.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change in insulin sensitivity (time frame: Day 1 and Week 5). 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 NCT01457209, which also lists 4 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 22 Jan 2014.

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