Obesity, polycystic ovarian syndrome/weight loss, fertility Nutritional, Metabolic, Endocrine Polycystic ovarian syndrome
Conditions
Interventions
1. If the patient successfully meets the eligibility criteria all will be invited to undergo an oral glucose tolerance test (OGTT)
2. Patients will be randomised
3. Every patient will be assigned to
Sponsors
Robert Gordon University (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Obese women body mass index (BMI) > 30 kg/m2 2. Aged between 20-40 years old who wish to conceive and have polycystic ovary syndrome (PCOS) as defined by the Rotterdam criteria, (2003)
Exclusion criteria
Exclusion criteria: 1. Previously diagnosed diabetics (both types 1 and 2) 2. History of renal disorder, hepatic disease, thyroid disease or cancer 3. Eating disorders 4. Weight altering medication 5. Weight loss > 2% in the last 3 months 6. Major cardiovascular or cerebrovascular event in the last 6 months 7. Pregnancy or lactation 8. Miscarriage in the last 3 months 9. Following contraception methods 10. Cardiac dysrhythmia 11. Porphyria (disorder of certain enzymes in the haeme biosynthetic pathway) 12. Thrombosis 13. Total lactose intolerance 14. Convulsions, seizures, epilepsy 15. Major depressive episodes, psychotic episodes, schizophrenia 16. Serious illness, injury or trauma/surgery in the last 3 months or due to undergo surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Weight loss-will be measured with subjects wearing light clothing and no shoes, on a calibrated digital scale (Tanita Body Composition Analyzer, type BC 410 MA III) 2. Ovulation-A calendar will be provided for the patients to keep track of their menses for the 12 month duration of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in hirsutism evaluated using the Ferriman Gallwey questionnaire 2. Changes in quality of life evalusated using theObesity-Related Well-Being (ORWELL 97) questionnaire 3. Changes in activity levels: a questionnaire adapted from the Framingham study, will be administered to the patients 4. Changes in body composition: For ensuring accuracy it will be determined by both air-displacement method (Bod Pod, Life Measurement Inc, USA) and whole body impendance analysis (Body Composition Analyzer BC-418MA, Tanita Corporation of America Inc., USA 5. Changes in androgen levels-Blood samples will be drawn and analysed for levels of testosterone, androstenedione, dehydroepiandrosterone sulfate (DHEAS), 17-alpha-hydroxyprogesterone (17-OHP) 6. Changes in lipid profile-Blood samples will be drawn and analysed for levels of low density lipoprotein (LDL), high density lipoprotein Level (HDL), total cholesterol levels and triglycerides 7. Changes in ACTH, cortisol 8. Changes in glycaemia and insulin sensitivity 9. Changes in levels of prolactin, progesterone, luteinising hormone (LH), follicle stimulating hormone (FSH), sex hormone binding globulin (SHBG) evaluated by blood tests Measured at at baseline, 6 and 12 months. | — |
Countries
United Kingdom
Outcome results
None listed