Polycystic ovary syndrome (PCOS) Pregnancy and Childbirth Polycystic ovary syndrome (PCOS)
Conditions
Interventions
The three-month individualized intervention involved changes in lifestyle designed to achieve weight loss. The diet was high in protein with little carbohydrate (40E% carbohydrates, 30E% fat and 30E%
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. All Rotterdam criteria for the diagnosis of PCOS should be met (anovulation, hyperandrogenism, polycystic ovaries) 2. 18-40 years 3. BMI >27 4. No medication or hormone-containing contraceptives for 3 months before beginning the study 5. Willing to sign informed consent Healthy controls: Women with normal weight with PCOS
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation during preceding 12 months 2. Smoking 3. Use of hormone-containing contraceptives 4. Current disease 5. Regular medication including insulin-sentizing drugs 6. Eating disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight change is measured using the body weight at baseline and 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Menstrual function is evaluated using recordings of menstrual pattern and blood sampling of hormones during the intervention. The menstrual function is considered to be improved from baseline to 12 weeks when there is a shift from amenorrhea to oligomenorrhea/regular menstruation or from oligomenorrhea to regular menstruation and/or ovulation is confirmed by increased serum progesterone >17 nmol/L 2. Insulin sensitivity of the endometrium is measured using determination of gene and protein levels of molecules involved in insulin signaling at baseline and 12 weeks 3. Endometrial hormone receptor expression is measured using determination of gene and protein levels of hormone receptors at baseline and 12 weeks | — |
Countries
Sweden
Outcome results
None listed