Polycystic ovary syndrome (PCOS) Nutritional, Metabolic, Endocrine Polycystic ovarian syndrome
Conditions
Interventions
Active treatment - individualized diet and exercise program:
The diet aims to reduce the intake of fast carbohydrates, in favour of foods with low glycemic index (GI), giving a smoothe
Sponsors
Karolinska Institutet (Sweden)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. All criteria for the diagnosis of PCOS should be met (anovulation, hyperandrogenism, polycystic ovaries) 2. 18-40 years 3. BMI between 27 and 38 4. No medication or hormone-containing contraceptives 5. If any kind of hormonal contraception, acceptance for three months of wash-out period before entering the study 6. Accepting a non-hormonal method of contraception such as condoms, IUD during the study or be sterilized 7. Willing to give informed consent in writing
Exclusion criteria
Exclusion criteria: 1. Smoking 2. Use of hormone-containing contraceptives 3. Chronic Illness 4. Ongoing medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight change Added 04/12/2019: measured in kilograms and a percentage at baseline, 4 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 04/12/2019: 1. Menstrual function defined as menstrual cycle type (regular cycle, oligomenorrhoea and amenorrhea) reported by participants at baseline, 4 and 12 months as well as changes to the proportion of study participants in each category at all review points 2. Body composition (total fat percentage, trunk fat mass and lean body mass) assessed by a dual-energy X-ray absorptiometry (DEXA) scanner at baseline, 4 and 12 months as well as changes to the body composition between baseline and the review points 3. Insulin sensitivity assessed by the oral glucose tolerance test, fasting insulin levels and the HOMA-index at baseline, 4 and 12 months and changes to these between baseline and the review points 4. Psychological well being as assessed by the Psychological General Well Being Index (PGWBI) at baseline, 4 and 12 months and changes to the PGWBI between baseline and the review points 5. Sleep pattern, measured by total sleep time, bedtime and wake up time and sleep efficiency. This is recorded using an Actigraph for 7 consecutive days at baseline and 4 months. 6. Metabolic status as measured by blood lipids, as well as metabolomic analysis of proteins specific for satiety and hunger. This will be done at baseline, 4 and 12 months 7. Liver fat as determined by MRI in a subset of patients at baseline and after 4 and 12 months Previous secondary outcome measures: 1. Menstrual function 2. Body composition 3. Insulin sensitivity in the endometrium, muscle and fat tissue | — |
Countries
Sweden
Outcome results
None listed