Polycystic ovary syndrome Nutritional, Metabolic, Endocrine Polycystic ovarian syndrome
Conditions
Interventions
The study group includes 66 patients (33 lean and 33 overweight/obese) with PCOS, Participants will be randomly allocated into treatment groups in a 1:1 ratio using stratification by body mass index (
Sponsors
University clinical center of Republika Srpska
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Polycystic Ovary Syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003 2. Age 18 - 40 years
Exclusion criteria
Exclusion criteria: 1. Significant liver or renal impairment 2. Other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs) 3. History of drug and alcohol abuse 4. History of breast and uterine cancer 5. Diagnosis of diabetes mellitus 6. Use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior to entering the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Adiponectin measured using blood test at baseline and six months (after 12 hours of fasting) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Body mass index (kg/m²) and body composition changes measured by bioelectrical impedance at baseline and six months 2. Testosterone level measured using blood test at baseline and six months (after 12 hours of fasting) 3. Glyco-insulinemic metabolism measured using area under the curve insulin post oral glucose tolerance test (AUC insulin), area under the curve glucose post oral glucose tolerance test (AUC glucose), quantitative insulin sensitivity check index QUICKI and homeostasis model assessment index HOMA IR at baseline and six months (after 12 hours of fasting) 4. Improvement/deterioration of clinical symptoms: hyperandrogenic features measured by Ferriman Gallwey score at baseline and six months | — |
Countries
Bosnia and Herzegovina
Outcome results
None listed