303
Participants
Start Date
December 31, 2015
Primary Completion Date
June 30, 2025
Study Completion Date
June 30, 2026
Lifestyle management
All women will receive lifestyle management instructions at the baseline visit, before randomization. The lifestyle management involves one initial counselling session in connection with the baseline visit, which includes information about the importance of weight management, healthy diet and physical activity.
Acupuncture
Disposable, single-use, sterilized CE marked needles made of stainless steel, 0.25 x 30 mm and 0.30 x 40/50 mm will be inserted to a depth of 15-40 mm in segmental acupuncture points located in abdominal and leg muscles, with innervations corresponding to the ovaries and the pancreas. Two sets of acupuncture points will be alternated every second treatment.
Metformin
Oral metformin 500 mg three times daily, in total 1500 mg per day. To reduce gastrointestinal side-effects of metformin, the dose will be slowly escalated starting with 500 mg daily during the first week, increasing to 500 mg twice per day during the second the week, and 500 mg three times daily, morning, lunch and dinner from the third week in total 16 weeks including the 3 weeks step-up phase (i.e. 4 months).
RECRUITING
Karolinska University Hospital, Stockholm
RECRUITING
Peking University, Beijing
Karolinska University Hospital
OTHER
Peking University
OTHER
Karolinska Institutet
OTHER