Actively Recruiting
Acupuncture or Metformin for Insulin Resistance in Women With PCOS
Led by Karolinska Institutet · Updated on 2024-10-09
303
Participants Needed
2
Research Sites
547 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Acupuncture or Metformin for Insulin Resistance in Women With PCOS
Who Can Participate
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 with at least two of the following: clinical signs of hyperandrogenism (hirsutism or acne), oligo/amenorrhea, or polycystic ovaries
- Hirsutism defined as Ferriman-Gallwey score 68 (or 65 for Asian women)
- Acne defined by self-report
- Oligomenorrhea defined as menstrual intervals longer than 35 days and fewer than 8 bleedings in the past year
- Amenorrhea defined as fewer than 3 cycles per year
- Polycystic ovaries defined by ultrasound with at least 12 follicles 2-9 mm or ovarian volume 6510 ml
- Willingness to sign informed consent
You will not qualify if you...
- Older than 40 years
- Other endocrine disorders such as non-classic congenital adrenal hyperplasia, androgen-secreting tumors, or suspected Cushing's syndrome
- Known kidney disease with creatinine clearance less than 60 mL/min
- Liver failure, autoimmune disorders, or cancer
- Any acute condition that may affect kidney function or cause tissue hypoxia
- Type 1 diabetes
- Use of certain medications (corticosteroids, antidepressants, antidiabetic drugs, hormonal contraceptives, hormonal ovulation induction) within 12 weeks, or Depo Provera within 6 months
- Allergy to metformin or its ingredients
- High blood pressure (greater than 160/100 mmHg)
- Pregnancy or breastfeeding within the last 6 months
- Acupuncture treatment within the last 2 months
- Daily smoking or alcohol consumption
- Language barriers or disabilities that reduce understanding of study information
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Peking University
Beijing, China, 100871
Actively Recruiting
2
Karolinska University Hospital
Stockholm, Sweden, 17176
Actively Recruiting
Research Team
E
Elisabet Stener-Victorin, PhD
CONTACT
B
Berit Legerstam, Study nurse
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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