Actively Recruiting
Led by Karolinska Institutet · Updated on 2024-10-09
303
Participants Needed
2
Research Sites
52 weeks
Total Duration
K
Karolinska Institutet
Lead Sponsor
K
Karolinska University Hospital
Collaborating Sponsor
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
Acupuncture or Metformin for Insulin Resistance in Women With PCOS
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Duration - 4 months
Participants receive lifestyle management instructions at baseline. Those assigned to acupuncture receive treatments three times per week for 4 weeks, then twice per week for 12 weeks. Those assigned to metformin take oral metformin daily with a dose escalation during the first 3 weeks, continuing treatment for a total of 4 months.
Multiple visits for acupuncture treatments or routine follow-up for metformin and lifestyle management
Duration - 4 months
Participants are monitored for another 4 months after treatment ends to assess lasting effects on metabolic, hormonal, and quality of life measures.
Follow-up visits for assessments after treatment completion
Total: 2 locations
1
Peking University
Beijing, China, 100871
Actively Recruiting
2
Karolinska University Hospital
Stockholm, Sweden, 17176
Actively Recruiting
E
Elisabet Stener-Victorin, PhD
B
Berit Legerstam, Study nurse
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Elisabet Stener-Victorin, Haolin Zhang, Rong Li...
https://pubmed.ncbi.nlm.nih.gov/30612112