Acupuncture or Metformin for Insulin Resistance in Women With PCOS

PHASE2RecruitingINTERVENTIONAL
Enrollment

303

Participants

Timeline

Start Date

December 31, 2015

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2026

Conditions
Polycystic Ovary SyndromeInsulin ResistanceHyperandrogenism
Interventions
OTHER

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.

DEVICE

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.

DRUG

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).

Trial Locations (2)

17176

RECRUITING

Karolinska University Hospital, Stockholm

100871

RECRUITING

Peking University, Beijing

All Listed Sponsors
collaborator

Karolinska University Hospital

OTHER

collaborator

Peking University

OTHER

lead

Karolinska Institutet

OTHER