ClinicalTrials.gov record NCT02647827

Acupuncture or Metformin for Insulin Resistance in Women With PCOS

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Acupuncture or Metformin for Insulin Resistance in Women With Polycystic Ovary Syndrome: A Randomized Controlled Trial

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.The registry record was last updated on Oct 9, 2024, about 2 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age18 years old to 40 years old
SexFemale
LocationChina, Sweden
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized trial compares three approaches for women with PCOS: electroacupuncture plus lifestyle advice, metformin plus lifestyle advice, and lifestyle advice alone. It enrolls women aged 18–40 with PCOS (BMI 25–40). Treatments are given for four months; metabolic, hormone and quality-of-life measures are assessed, and some participants have tissue biopsies and further follow-up.

What it is studying. The study tests whether adding electroacupuncture or oral metformin to lifestyle counseling changes whole-body glucose control in women with PCOS. Primary measurements are insulin sensitivity (HOMA-IR), insulin response during an oral glucose tolerance test (OGTT), and HbA1c after four months. The study also examines reproductive hormones, ovulation, quality of life, symptoms of anxiety/depression, metabolic markers, and gene expression and DNA methylation in fat, muscle and endometrial tissue.

What the researchers hope to learn. To determine whether electroacupuncture or metformin (each combined with lifestyle management) affects insulin sensitivity and glucose regulation compared with lifestyle management alone. Secondary goals include studying changes in other metabolic measures, reproductive hormones and ovulation, quality of life and mental-health symptoms, tissue-level gene expression and DNA methylation related to insulin sensitivity, and cost-effectiveness.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The hypothesis is that acupuncture is equally effective as metformin (both treatments combined with lifestyle management) in improving whole body glucose homeostasis in insulin resistant women with polycystic ovary syndrome (PCOS), and that both are superior to lifestyle management alone. The investigators hypothesize that acupuncture and metformin induce ovulation and improve hyperandrogenism, as well as health related quality of life (HRQoL) and symptoms of anxiety and depression. Although equally effective (acupuncture and metformin), the investigators hypothesize that acupuncture is associated with less negative side-effects. The investigators also hypothesize that these treatments have the potential to restore epigenetic and molecular alterations in target tissues (endometrial-, adipose-, and skeletal muscle tissue) and thus have the potential to prevent the development of type 2 diabetes (T2D).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Metformin
Device
  • Acupuncture
Other
  • Lifestyle management

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • women with PCOS:
  • Age 18 to 40 years
  • Body mass index (BMI) ≥25 to ≤40 given that 95% of all women with PCOS with a BMI ≥25 are insulin resistant (71,72).
  • PCOS diagnosis according to Rotterdam criteria 2003 (73), with at least two of the following three symptoms: Clinical signs of hyperandrogenism (hirsutism or acne); oligo/amenorrhea; and/or polycystic ovaries (PCOS). Hirsutism is defined as a self-reported Ferriman-Gallwey (FG) score ≥8 (≥5 Asian) (74,75). Acne is defined by a positive response to the question Do you have acne? Oligomenorrhea is defined as an intermenstrual interval >35 days and <8 menstrual bleedings in the past year. Amenorrhea as <3 cycles per year. PCO is defined by transvaginal ultrasound with ≥12 follicles 2-9 mm and/or ovarian volume ≥10 ml in one or both ovaries.
  • Willing to sign the consent form.
  • Inclusion criteria - controls:
  • Controls should have BMI >25 to <40, regular cycles with 28 days ± 2 days, and no signs of hyperandrogenism. They are excluded if they have menstrual irregularities, signs of hyperandrogenism (FG >4), or evidence of PCO morphology on ultrasound.

Exclusion criteria

  • for all women
  • Age >40
  • Exclusion of other endocrine disorders such as non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L), androgen secreting tumors or suspected Cushing's syndrome.
  • Having known renal disease (creatinine clearance < 60 mL/min), hepatic insufficiency, autoimmune disorders or cancer.
  • Any acute condition with potential to alter renal function or cause tissue hypoxia.
  • Type I diabetes.
  • Pharmacological treatment (cortizon, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months.
  • Hypersensitivity to metformin hydrochloride or to any of the excipients.
  • Blood pressure >160 / 100 mmHg
  • Pregnancy or breastfeeding the last 6 months
  • Acupuncture the last 2 months
  • Daily smoking and alcoholic intake
  • Language barrier or disabled person with reduced ability to understand the information given.
  • In total 50 controls will be matched at baseline (age, weight and BMI) to women with PCOS. Controls will undergo screening and baseline visit, but will not be randomized to any treatment.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

Specific Aims The purpose of the study is to perform a randomized controlled trial of women with PCOS, comparing the effectiveness of lifestyle management alone, and in combination with acupuncture or metformin treatment on whole body glucose homeostasis, with the ultimate goal to prevent the development of type 2 diabetes. Primary aim

  • To determine the clinical effectiveness of 4 months of 1) electroacupuncture + lifestyle management and 2) metformin + lifestyle management, compared to 3) lifestyle management only, for improvement of insulin sensitivity as measured by HOMA-IR, by the insulin response to glucose assessed by calculating the area under the curve (AUCinsulin) during the oral glucose tolerance test (OGTT), and by glucose regulation (assessed by analyzing Hba1c levels).

Secondary aims

  • To evaluate changes in secondary metabolic measures, including fasting insulin, c-peptide, glucose, and adipokines, calculation of HOMA-B (i.e. the Islet β-cell function) and the c-peptide index, assessment of the adipokines and lipid profile, body size and proportions and body fat distribution.
  • To determine changes in genome-wide gene expression and DNA methylation profiles related to insulin sensitivity in fat, muscle and endometrial tissue biopsies, and biomarkers in whole blood.
  • To evaluate endocrine measures including menstrual pattern and ovulation frequency, circulating hormones (sex steroids, AMH, gonadotropins), and excretion of metabolites of sex steroids in urine.
  • To determine changes in women's HRQoL, symptoms of anxiety and depression, dieting and eating patterns, and negative side-effects.
  • To evaluate the cost-effectiveness of the different treatments.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

All participants get one initial lifestyle-counselling visit. Eligible women are randomized to one of three groups: lifestyle management alone, lifestyle plus acupuncture (three treatments per week for 4 weeks, then twice weekly for 12 weeks), or lifestyle plus oral metformin (dose escalated over 3 weeks to 500 mg three times daily for a total of 16 weeks/4 months). Study testing includes blood tests and an oral glucose tolerance test; some participants will have tissue biopsies (fat, skeletal muscle, endometrium), menstrual tracking, and questionnaires about quality of life, mood and eating; key outcomes are measured after 4 months and again about 4 months after treatment ends. Controls undergo screening and a baseline visit only and are not randomized.

How the study is structured. Randomized, open (not masked), parallel-group trial with three arms: 1) lifestyle advice alone, 2) electroacupuncture plus lifestyle advice, and 3) metformin plus lifestyle advice. Treatment period is four months; some outcomes are reassessed four months after the end of treatment. Metformin is given orally with a 3-week dose escalation to 1,500 mg/day; acupuncture is given multiple times per week during the 4-month treatment. Participants undergo metabolic testing (OGTT), blood tests, questionnaires, and some tissue biopsies.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Polycystic Ovary Syndrome; Insulin Resistance; Hyperandrogenism. Does it apply to my diagnosis?
  • The listed sites are in China, Sweden. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
December 2015
Primary completion
June 2025 (estimated)
Study completion
June 2026 (estimated)
Target enrollment
303 participants (estimated)
Last updated on registry
Oct 9, 2024
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Karolinska Institutet
Principal investigator
Elisabet Stener-Victorin, PhD, Associate Professor
Karolinska Institutet
Collaborators
  • Karolinska University Hospital
  • Peking University

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (2)

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
creatinine clearance
A measure of kidney function, calculated from a blood creatinine level together with age, weight and sex.
baseline
Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.
randomized
Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
Exclusion criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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