The BAMBINI clinical trial is a randomized clinical trial looking at the effects of bariatric (weight loss) surgery vs. lifestyle intervention in premenopausal women over the age of 18 with a diagnosis of polycystic ovarian syndrome, body mass index ≥ 35 kg/m2 and less than 8 menstrual periods a year. There are two research sites – Hammersmith Hospital, London and University Hospital Coventry & Warwickshire, Coventry.
Eligible participants will need to use barrier contraception for the duration of the trial and be off any hormonal treatment for at least 6 -8 weeks prior to the initial screening visit. Each participant will be enrolled in the trial for roughly 14-16 months.
Follow up includes monthly clinical visits with the research team and weekly progesterone blood tests at either Imperial College Healthcare NHS Trust (Charing Cross/Hammersmith/St Marys Hospitals) phlebotomy department or, University Hospital Coventry & Warwickshire.
Participants in the surgical group will undergo a vertical sleeve gastrectomy. Participants in the lifestyle intervention group will have regular sessions with a specialist dietician.
Upon completion of the trial, participants in the lifestyle intervention group will be offered a referral for bariatric surgery within the trust if desired.