Polycystic ovarian syndrome, obesity Nutritional, Metabolic, Endocrine Polycystic ovarian syndrome, obesity
Conditions
Interventions
Patients will be randomised at a ratio of 1:1, stratified by BMI and trial site (using an online randomisation tool).
Intervention - obesity surgery
Control - standard medical care
Participants wil
Sponsors
Imperial College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 20/02/2023: 1. Pre-menopausal women 18 years and older 2. BMI more than or equal to 35 kg/m² with obesity-related complications 3. Diagnosis of PCOS based on international evidence-based guidelines for the assessment and management of PCOS 2018 Previous inclusion criteria: 1. Pre-menopausal women 18 years and older 2. BMI more than or equal to 35 kg/m² 3. Obesity-related complications 4. Diagnosis of PCOS based on international evidence-based guidelines for the assessment and management of PCOS 2018 5. Polycystic ovaries on ultrasound
Exclusion criteria
Exclusion criteria: 1. Type 1 or 2 diabetes mellitus 2. Specific contraindications to obesity surgery 3. Previous obesity surgery 4. Inability to maintain adequate contraception 5. Use of medications affecting reproductive function at screening/3 months prior 6. Other causes of anovulation 7. Current pregnancy/breastfeeding 8. Any medical/psychological/other condition which would potentially either interfere with the study or cause harm to the volunteer 9. Without access at home to a telephone or other factor likely to interfere with the ability to participate reliably in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 20/02/2023: Number of ovulatory cycles within the 12 months follow-up period - defined as a rise in serum progesterone =16 nmol/L, measured using weekly blood progesterone levels Previous primary outcome measure: Number of ovulatory cycles within the 12 months follow-up period - defined as a rise in serum progesterone >20 nmol/L, measured using menstrual diaries and weekly blood progesterone levels | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 20/02/2023: Measured at baseline and then monthly for 12 months (except oral glucose tolerance test): 1. Reproductive profile, liver function tests, lipid profile, HbA1C using blood test 2. Severity of anxiety and depression symptoms measured using the hospital anxiety and depression score (HADS) 3. Multidimensional health profile: health functioning questionnaire score, social functioning questionnaire score, PCOS health-related quality of life score, modified Ferriman-Galwey hirsuitism score, Ludwig visual score, Savin Alopecia Scale score, Cardiff Acne Disability Index 4. Arterial blood pressure (mmHg) 5. Oral glucose tolerance test (at baseline, 6 months and 12 months) 6. Body weight (kg) 7. Waist circumference (cm) 8. Body composition 9. Number of medications measured using patient records 10. Adverse events measured using patient records 11. Pregnancy rates measured using patient records Previous secondary outcome measures: Measured at baseline and then monthly for 12 months (except oral glucose tolerance test): 1. Reproductive profile, liver function tests, lipid profile, HbA1C using blood test 2. Mental health measured using the Hospital anxiety and depression scale 3. Multidimensional health profile: health functioning questionnaire score, social functioning questionnaire score, PCOS health-related quality of life score, modified Ferriman-Galwey hirsuitism score, Ludwig visual score, Savin Alopecia Scale score, Cardiff Acne Disability Index 4. Arterial blood pressure (mmHg) 5. Oral glucose tolerance test (only baseline and 6 months) 6. Body weight (kg) 7. Waist circumference (cm) 8. Body composition 9. Number of medications measured using patient records 10. Adverse events measured using patient records 11. Pregnancy rates measured using patient records | — |
Countries
England, United Kingdom
Contacts
Public ContactSuhaniya Samarasinghe
Outcome results
None listed