What is metformin studying for insulin resistance in women with PCOS?

Metformin is being studied to see how it compares to acupuncture and lifestyle management in improving insulin sensitivity in women with PCOS. Researchers want to understand how these treatments affect glucose control, ovulation, hormone levels, and quality of life. The study is led by Karolinska Institutet to help prevent type 2 diabetes in this group.

Who may be eligible for this PCOS clinical trial?

Women aged 18 to 40 with a diagnosis of PCOS based on specific criteria may be eligible. Participants need a body mass index between 25 and 40 and must not have recent use of certain medications like hormonal contraceptives or antidiabetic drugs. Only females can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this PCOS clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can plan accordingly for any travel or accommodation needs.

Actively Recruiting

Phase 2

Age: 18Years - 40Years

FEMALE

Healthy Volunteers

ID02647827

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

Led by Karolinska Institutet · Updated on 2024-10-09

303

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of acupuncture compared to metformin, both combined with lifestyle management, in improving glucose control in women with insulin resistance and polycystic ovary syndrome PCOS. The study aims to see if these treatments improve ovulation, hormone balance, quality of life, and symptoms of anxiety and depression, while also investigating if acupuncture has fewer side effects. They also explore whether these treatments can reverse molecular changes that may help prevent type 2 diabetes. Participants will be randomly assigned to one of three groups lifestyle management alone, lifestyle management plus acupuncture, or lifestyle management plus metformin. Acupuncture treatments involve inserting sterile needles into specific abdominal and leg acupuncture points related to ovarian and pancreatic function, administered three times weekly for four weeks, then twice weekly for twelve weeks. Metformin is taken orally, starting at a low dose and gradually increasing to 1500 mg daily over 16 weeks. All women receive lifestyle advice on weight management, diet, and exercise at the start. During the study, participants undergo assessments at the start, after 4 months of treatment, and again 4 months post-treatment. These include blood tests measuring insulin sensitivity, glucose levels, hormone levels, and molecular markers from tissue samples. Researchers will also monitor menstrual patterns, ovulation, quality of life, mental health symptoms, eating habits, and treatment side effects. The study lasts 8 months with ongoing evaluations to determine the cost-effectiveness and overall impact of each treatment approach.

CONDITIONS

Brief Title

Acupuncture or Metformin for Insulin Resistance in Women With PCOS

Who Can Participate

Age: 18Years - 40Years

FEMALE

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Women aged 18 to 40 years
Body mass index (BMI) between 25 and 40
Diagnosed with PCOS according to Rotterdam criteria 2003, with at least two of: clinical signs of hyperandrogenism (hirsutism or acne), oligo/amenorrhea, or polycystic ovaries on ultrasound
Hirsutism defined as Ferriman-Gallwey score 8 or higher (5 or higher for Asian women)
Acne defined by positive response to having acne
Oligomenorrhea defined as menstrual intervals over 35 days and fewer than 8 periods in the past year
Amenorrhea defined as fewer than 3 cycles per year
Polycystic ovaries defined by ultrasound showing 12 or more follicles sized 2-9 mm or ovarian volume 10 ml or more
Willing to sign consent form

You will not qualify if you...

Age over 40 years
Other endocrine disorders such as non-classic congenital adrenal hyperplasia, androgen-secreting tumors, or suspected Cushing's syndrome
Known kidney disease (creatinine clearance below 60 mL/min), liver failure, autoimmune disorders, or cancer
Any acute illness that may affect kidney function or cause tissue hypoxia
Type 1 diabetes
Use of cortisone, antidepressants, other antidiabetic drugs, hormonal contraceptives, hormonal ovulation induction, or other investigator-judged drugs within 12 weeks (Depo Provera or similar within 6 months)
Allergy to metformin or its ingredients
Blood pressure higher than 160/100 mmHg
Pregnancy or breastfeeding within the past 6 months
Acupuncture treatment within the last 2 months
Daily smoking and alcohol consumption
Language barriers or reduced ability to understand study information

Research Team

Elisabet Stener-Victorin, PhD

Berit Legerstam, Study nurse

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